Company: Makro Technologies Inc
Date: 09/06/2008
Location: Danvers
State of Job: Massachusetts
Person to Contact: srikanth
Contact phone or email: srikanth.kadakanc@makrotech.com
Title of Job: Materials Engineer
Description:
Urgent requirement for one of our top clients located in “Danvers, MA ” Please contact me at your earliest convenience, along with job No.ME_090608 as a Subject to srikanth.kadakanc@makrotech.com
Job Title :Materials Engineer
Full Requirement : Source new and improved extrusion and braiding manufacturing methods for their application and/or adaptation to flexible composite medical device profiles. This individual will provide direct supervision of an Extrusion Work Cell and manage capacity requirements for development and production.
Position Responsibilities • Manage specific individual project schedules and capital acquisition budgets • Source and acquire lab testing instrumentation to perform thermal and mechanical analyses of compounded resins and post-extruded samples. • Investigate new applications to leverage existing technologies. Collaborate with Team Engineers to develop product line extrusions and new product concepts to release to production. • Devise and implement cost savings proposals related to extrusion process and work flow improvements.
Requirements:
EDUCATION • BS/MS Plastics Engineering
JOB EXPERIENCE • Three or more years of extrusion process/project engineering experience.
Other:
Company: Director of Regulatory and Clinical
Date: 09/05/2008
Location: Outside Baltimore Maryland
State of Job: Not New England
Person to Contact: Shawn Schantz
Contact phone or email: sschantz@prestigescientific.com 508-422-9322
Title of Job: Director of Regulatory and Clinical
Description:
Large Medical Device Manufacturer known for the leading edge technology thru numerous therapeutic platforms is currently looking for a Director of Regulatory/Clinical Affairs. Overseeing a department of 4, you will be responsible for Regulatory Strategies, filings and interpetation of Clinical Data (US based)
Requirements:
* 7+ yrs pf Medical Device Regulatory Affairs * BS/MS in science/engineering * Proven leadership experience overseeing small teams * Ability to wear many hats when needed. Client offers an impressive base/bonus compensation, and relocation assistance for those that need it.
Other:
Company: Nachman BioMedical
Date: 09/04/2008
Location:
State of Job: Massachusetts
Person to Contact: Phil Nachman
Contact phone or email: phil@nachmanbiomedical.com
Title of Job: Manager / Principal Mechanical Engineer
Description:
Manager / Principal Mechanical Engineer
Growth opportunity at a promising early stage surgical device company with exciting technology and strong market opportunity.
SUMMARY:
Excellent career opportunity for a hands-on Manager or Principal Mechanical Engineer with significant, successful experience in the design of surgical instruments,complex mechanisms, and/or robotics components. This seasoned engineer will have a lead role in developing, documenting, and validating new product designs for the company’s proprietary surgical robotic products, as well as improving existing designs to meet the needs of customers. He or she will work with a terrific team of highly experienced and motivated medical device development, motion control, and surgical robotics experts creating a new generation of easy to use systems for more precise surgery.
RESPONSIBILITIES:
Design major mechanical assemblies and components for robotic surgical systems Design and develop major product subsystems Lead a team of internal and external resources to complete complex designs Create IP to support the company’s long-term goals. Identify, direct vendors to modify, enhance their technologies to integrate more fully into the designs. Investigate clinical requirements and produce subsystem specifications Support production by troubleshooting process and component problems Train sales, marketing professionals on technical aspects of designs being created
REQUIREMENTS:
BSME required, MSME preferred A minimum of 7 years experience designing commercial mechanical products, including surgical instruments and/or robotics; greater experience is welcome Proven ability to create and deliver subsystems that consider the mechanical aspects as well as other disciplines (SW, HW, industrial design, etc.) Track record bringing multiple designs to production, with focus on DFM and reliability. Proven capability to lead multi-person teams comprised of internal and external resources in design / development of complex mechanisms, ideally for motion control Injection molding and plastics design experience Able to mentor junior engineers and technicians Development experience in medical devices and instrumentation, and/or robotics. Experience in a start-up environment is highly desired. Knowledgeable with all phases of the product development lifecycle including feasibility, design input creation, verification, qualification, and transfer Proficiency with CAD, ProE and/or SolidWorks preferred
Requirements:
BSME required, MSME preferred A minimum of 7 years experience designing commercial mechanical products, including surgical instruments and/or robotics; greater experience is welcome Proven ability to create and deliver subsystems that consider the mechanical aspects as well as other disciplines (SW, HW, industrial design, etc.) Track record bringing multiple designs to production, with focus on DFM and reliability. Proven capability to lead multi-person teams comprised of internal and external resources in design / development of complex mechanisms, ideally for motion control Injection molding and plastics design experience Able to mentor junior engineers and technicians Development experience in medical devices and instrumentation, and/or robotics. Experience in a start-up environment is highly desired. Knowledgeable with all phases of the product development lifecycle including feasibility, design input creation, verification, qualification, and transfer Proficiency with CAD, ProE and/or SolidWorks preferred
Other:
Company: Wilmark Group
Date: 09/04/2008
Location: Southborough
State of Job: Massachusetts
Person to Contact: Jason Blasbalg
Contact phone or email: jasonb@wilmark.com
Title of Job: Optical Engineer
Description:
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Optical Engineer will work directly with the Senior Optical Engineer, Principal Lens Designer, and other R&D staff developing and testing imaging products for medical applications. Responsibilities and activities will include the following:
· Design of optical systems for rigid endoscopes, flexible endoscopes, and digital electronic endoscopes. · Design of optical systems for single and 3-chip cameras. · Trouble shooting optical problems on existing visualization product lines. · Optical specification, tolerancing, and design of thin film lens coatings. · Working directly with mechanical and electronics designers on the integration of optics into instrument designs. · Perform design analysis (tolerance stack-ups). · Perform stray-light analysis. · Building, testing, and evaluating prototype optical designs. · Documenting designs and transferring them to production. · Interface with outside vendors in optical component production and process design. · Interface with internal workgroups, Machine Shop, Quality Engineering, Production, etc..
All Other Essential Duties as directed.
Requirements:
EDUCATION AND/OR EXPERIENCE •
B.S. Degree in Optical Engineering or Optical Science is required plus 3 to 5 years of design and development experience. The candidate should have demonstrated hands-on experience handling optics, assembling optical prototypes, testing optical systems, and working in an optical lab environment. Experience working in a class 10,000 or better clean environment is also desirable. Familiarity with lean manufacturing, design for six-sigma, and ISO9001 is desirable. The ideal candidate will also have experience in an FDA regulated industry.
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES
· Exceptional written and verbal communication skills. · 3-5 years experience designing and testing imaging optics and systems. · Working knowledge of optical CAD software either Zemax or Code V is required. · Knowledge of imaging technology such as CCD/CMOS sensors, display devices, light sources, couplers, and light guides. · Working knowledge of practical dimensioning and tolerances for small optical components. · Familiarity with ISO 10110. · Experience in a regulated development environment (e.g., ISO9001) preferred. · Background in the medical device industry preferred.
LANGUAGE SKILLS (verbal, written, listening), SOFTWARE SKILLS, ANALYTICAL SKILLS, MATHEMATICAL SKILLS, PRESENTATION SKILLS, TEAM PLAYER, ETC.
The Optical Engineer should demonstrate a willingness to learn and take direction, a cooperative team attitude in working with a range other employees, and creativity in contributing to new product development. Written and verbal communication skills must be sufficient to read and understand documentation and communicate with, and take technical instruction from, co-workers, supervisors, and other professional personnel. Proficiency using Microsoft Office software suite including Word, Excel, and Outlook is also required.
Other:
Company: Wilmark Group
Date: 09/04/2008
Location: Southborough
State of Job: Massachusetts
Person to Contact: Jason Blasbalg
Contact phone or email: jasonb@wilmark.com
Title of Job: International Regulatory Affairs Specialist
Description:
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Participate in product teams developing new products to define global regulatory requirements. • Review and approve product labelling and advertising. Work closely with Marketing in developing labelling materials. • Develop, coordinate, prepare and maintain US medical device submissions such 510ks, PMAs, IDEs and applicable supplements and annual reports and liaise with FDA reviewers as needed. • Develop, coordinate, prepare and maintain International medical device submissions such as EU design dossiers & technical files and Canadian Class 3/ 4 submissions and product registrations in markets such as Japan, the Far East, Australia and Latin America. Respond to regulatory authorities and/or distributor’s requests for additional information. • Interface with foreign distributors and international regulatory authorities and notified bodies as necessary to assure company products comply with country requirements. Work closely with International Marketing Department to implement company business plans. • Obtain Certificates of Product for Export or other applicable export notifications from FDA as needed. • Assist with the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management. • Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes. Advise regulatory management of changes and as appropriate communicate regulatory initiatives or changes to other COMPANY staff. • Assist with the tracking of external standards applicable to company products and processes and maintenance of corporate standards library/index and communication of proposed/implemented changes to company staff. • As needed, assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
Secondary responsibilities of this position include:
• Assist with compliance activities related to GMP and ISO regulations and ISO quality system standards. May assist in the performance of internal quality and regulatory compliance audits and the evaluation and monitoring of corrective actions. • Assist Managers during quality inspections by FDA and International Regulatory Agencies. • Responsible for responding to requests for information during inspections. • Review product and process documentation for assigned projects to insure compliance with change control requirements and determining whether regulatory submissions are required. • All Other Essential Duties as directed
Requirements:
EDUCATION AND/OR EXPERIENCE •
BS/BA required, preferably in engineering or life sciences. • Regulatory affairs experience in the Medical Device industry is mandatory [minimum 3-5 years preferred]. • You must be able to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word, Excel or Access, PowerPoint).
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES
Must be able to travel to COMPANY facilities in the US. The ideal candidates will have the following abilities:
• Ability to work in small team environment, but also self-starter with ability to work independently. • Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors. • Must be able to meet deadlines and be detailed orientated. Good planning and organization skills a must. • Strong critical thinking and problem solving skills. • Documented continuing education in regulatory affairs and RAC Certified is a plus.
Other:
Company: Wilmark Group
Date: 09/04/2008
Location: Southborough
State of Job: Massachusetts
Person to Contact: Jason Blasbalg
Contact phone or email: jasonb@wilmark.com
Title of Job: Sr. Optical Technician
Description:
ESSENTIAL DUTIES AND RESPONSIBILITIES (List of 8-10 key tasks required of the job which occupy greater than 5% of the incumbents time)
The Senior Optical Technician will work directly with the Optical Engineers, Lens Designers, and other R&D staff developing and testing imaging products for medical applications. Responsibilities and activities will include the following:
· Trouble shooting optical problems on existing visualization product lines. · Working with mechanical and optical designers on the development of new optical designs. · Working directly with mechanical and electrical designers on the integration of optics into instrument designs. · Building, testing, and evaluating prototype optical designs. · Fabricating any necessary test fixtures and setups. · Making precise measurements of mechanical and optical components. · Assembling component parts according to specifications (Optical, Mechanical & Electrical). · Precision assembly of small parts under microscope. · Testing and rework of products for correct functioning. · Performing optical system testing and generating reports. · Engaging in design reviews and providing feedback to R&D for design improvements. · Assisting Production organization in initial manufacturing ramp-up. · Interfacing with internal workgroups, Machine Shop, Quality Engineering, Production, etc..
All Other Essential Duties as directed.
Requirements:
Associates Degree in Optics Technology or Optical Engineering plus 5 to 7 years of relevant experience. The candidate should have demonstrated hands-on experience handling optics, assembling optical prototypes, testing optical systems, and working in an optical lab environment. Experience working in a class 10,000 or better clean room environment is also desirable. Familiarity with lean manufacturing, design for six-sigma, and ISO9001 is desirable. The ideal candidate will also have experience in an FDA regulated industry.
Other:
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES
· Communication skills adequate to take instructions from the Engineering staff. · Knowledge of imaging technology such as CCD/CMOS sensors, display devices, light sources, couplers, and light guides. · 3-5 years experience assembling and testing imaging optics and systems. · Proven experience in a job demonstrating excellent manual dexterity and ability to work under a microscope. · Familiarity with operating electronics and optical test and measurement equipment (e.g. light meters, oscilloscopes, resolution targets, etc.). · Experience in a regulated development environment (e.g., ISO9001) preferred. · Background in the medical device industry preferred.
LANGUAGE SKILLS (verbal, written, listening), SOFTWARE SKILLS, ANALYTICAL SKILLS, MATHEMATICAL SKILLS, PRESENTATION SKILLS, TEAM PLAYER, ETC.
The Senior Optical Technician should demonstrate a willingness to learn and take direction, a cooperative team attitude in working with a range other employees, and creativity in contributing to new product development. Written and verbal communication skills must be sufficient to read and understand documentation and communicate with, and take technical instruction from, co-workers, supervisors, and other professional personnel. Basic proficiency using Microsoft Office software suite including Word, Excel, and Outlook is also required.
Company: Biomedical Search Consultants
Date: 08/29/2008
Location: Burlington
State of Job: Massachusetts
Person to Contact: Steve Butler
Contact phone or email: sbutler@biomedicalsearchconsultants.com
Title of Job: Quality Engineer
Description:
Job Summary:
Our confidential client has an immediate need for two experienced quality engineers (one role is more software focused) who are looking for a chance to make a very cool product that immediately impacts the quality of life for real people! This position is responsible for quality engineering/quality assurance activities. This includes interpretation and implementation of quality standards to product development and routine manufacturing activities.
Essential Duties and Responsibilities:
• Implement and maintain quality system in accordance to applicable regulatory requirements. • Develop and upgrade procedures required by the quality system • Develop and maintain Supplier Quality Assurance System • Monitor suppliers’ performance through surveys/ audits • Work with suppliers to resolve quality issues, through the supplier CAPA process • Issue supplier corrective actions and track supplier quality metrics • Assist suppliers in product improvement initiatives • Perform Internal Quality Audits of the quality system • Participate on cross-functional product development teams • Develop qualification/validation plans. • Conduct product/process validations • Set up inspection/metrology equipment and Incoming Inspection processes • Supervise quality testing and inspection activities • Develop and implement statistical sampling plans • Trend in- process data • Other duties as assigned
Requirements:
Qualifications:
Bachelor of Science in Engineering or Science Individual must have 3-5 years of Quality Assurance/Quality Engineering experience in a FDA regulated environment – preferably QSR (21 CFR Part 820)
Skills, Abilities, Competencies Required:
Must be proficient with FDA and ISO standards for Medical Devices. Must have good communication skills. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
Other:
Company: OPTIM Incorporated
Date: 08/28/2008
Location: Sturbridge
State of Job: Massachusetts
Person to Contact: Bob Krupa
Contact phone or email: r.krupa@optimnet.com
Title of Job: Mechanical Engineer
Description:
Duties and Responsibilities:
•Innovate, develop, and design opto-mechanical assemblies, instruments, and accessories. •Plan for the most cost-effective utilization of materials and processes in the design of medical and industrial endoscopes, both fiber optic and video-based, and LED-based light sources. •Lead and/or participate in interdisciplinary product design teams. •Design and perform engineering tests and experiments. •Take projects from concept to production. •Take ownership and responsibility for the on-time completion of project goals. •Work independently under the supervision of the Engineering Manager to plan and schedule activities to meet project timelines. •Produce engineering and manufacturing documentation for new products.
Requirements:
Knowledge and Experience:
•Requires a bachelor’s degree in engineering and at least 4 years experience in Mechanical Engineering, preferably in the design of endoscopic or opto-mechanical products. •Working knowledge of 3D Modeling and 2D CAD in SolidWorks. •Proven ability to organize, coordinate, and lead projects and project teams. •Strong communication and interpersonal skills. •Ability to think creatively in the design of innovative solutions to customers’ problems using the firm’s endoscopic technology and expertise. •Familiarity with ISO and FDA practices and regulations a plus. •Course study or experience with fiber optics, LEDs, video cameras and displays, and electronics a plus.
Other:
To visit our website, go to www.optimnet.com
Company: Prestige Scientific
Date: 08/20/2008
Location: North Shore
State of Job: Massachusetts
Person to Contact: Shawn Schantz
Contact phone or email: 508-422-9322 sschantz@prestigescientific.com
Title of Job: Process Engineer
Description:
Boston Based Medical Device Manufacturer of capital equipment is currently looking for a Senior Process engineer to join their team. The technology is exciting and the team/environment is fun.
Requirements:
* 5 years of Engineering experience * 1-3 years experience in fabrication of silicone wafers mechanical process * BS/MS in Engineering For consideration of this or other exciting opportunities within the Medical Device community, please send a Word Document resume for consideration.
Other: http://recruitershawn.blogspot.com
Company: Biomedical Search Consultants
Date: 8/19/08
Location: Greater Boston
State of Job: Massachusetts
Person to Contact: Kathy Provost
Contact phone or email: kprovost@biomedicalsearchconsultants.com
Title of Job: Senior Release and Tools Engineer
Description:
Our client is a leader in the design and production of patient-specific medical devices for the dental market. Due to growth, they are expanding and are seeking a Senior Release and Tools Engineer to join the team. This is a great opportunity if you are seeking to join a highly innovative and financially solid industry leader that promises challenging work and excellent career growth opportunities!
Responsibilities
The position provides an opportunity with continuous challenge in extending our client’s capabilities. You will help update the client’s release and build processes to support growth, and deliver consistent, predictable and reproducible software builds. You will also play a key role in decoupling the various software components so they can be built and released independently and at different release levels for use at multiple manufacturing facilities. The Senior Release and Tools Engineer will be responsible for creating and executing build and release plans, automating the build environment and generating schedules, reports and metrics. You will also identify build and release tools and protocols, and maintain the build hardware, tools and infrastructure.
Requirements:
Experience Required
• A minimum of 5 years of experience in a software release and tools environment, with a minimum of 3 year of practical experience with build tools for C++ or Java in a Microsoft and/or Unix environment. • Experience with make tools, scripting languages, conditional compilation, version control, defect tracking tools, and install tools • Experience with database environments and object oriented development environments a plus. • Experience implementing new release and tools methodologies highly desirable • Experience with the requirements of a regulated environment highly desirable • Experience with life-cycle software development: requirements, specification, design, testing, implementation, and debugging/support • Ability to work independently in a small development group with minimum supervision Skills Required • Working knowledge of software development methodologies and tools, including experience with automated build systems, version & project control • Ability to communicate easily in written and spoken English Education Required AS/BS degree in Computer Science or Engineering discipline or equivalent experience preferred
Other:
Please submit resume to: kprovost@biomedicalsearchconsultants.com For more information, please visit www.biomedicalsearchconsultants.com
Company: Process Engineer
Date: 08/19/2008
Location: Metro West 495
State of Job: Massachusetts
Person to Contact: Debbie Rausch
Contact phone or email: corporate.growth@yahoo.com
Title of Job: Process Engineer
Description:
Some duties/responsibilities:
Lead continuous improvement through regularly scheduled assessments and closed loop corrective action implementation In conjunction with quality, respond efficiently and effectively to address product quality issues Initiate and manage supplier CAPAs to successful closure
Requirements:
* 5+ years of Process Engineering within Medical Devices * Must have a Technical degree * Ability to design PCB boards * ABility to test these boards
For consideration for this or other exciting opportunities wthin the Medical Device vertical market please send me a Word Document resume for confidential review.
Other:
http://recruitershawn.blogspot.com/2008/08/job-openings-week-of-august-4th.html
Company: Corporate Growth Resources
Date: 08/19/2008
Location: Framingham area
State of Job: Massachusetts
Person to Contact: Debbie Rausch
Contact phone or email: corporate.growth@yahoo.com
Title of Job: Principal Systems Engineer
Description:
· Work across engineering functions to define, architect, and direct the implementation of projects related to aesthetic laser systems and accessories. · Preside over comprehensive design reviews and ensure that projects are maintained to the product development process. · Work cross functionally (marketing, clinical, service, manufacturing, regulatory, and quality organizations) to identify and document product requirements. · Work within engineering to translate product requirements into design specifications · Develop and maintain the system requirements specification and test plans for the project with emphasis on subsystem interfaces. · Create and maintain system test protocols for design verification and validation · Execute testing to prescribed protocols, documenting results and creating final reports · Maintain traceability between requirements, design, and testing · Ensure the correctness and adequacy of documentation on assigned projects. · Ensure compliance with design controls and all regulatory requirements. · Develop and document analytical models of system and subsystem behavior and interactions. · Work with the PM to define and maintain system integration activities within the project. · Prepare for and participate in comprehensive design reviews · Take on responsibility as technical project lead managing internal as well as external resources. · Develop and document best practices for the systems engineering group. · Work with R&D to formulate concepts for new or enhanced products and architectures · Contribute to product development planning.
Requirements:
· MS in electrical, mechanical, optical, or computer engineering · Minimum of 10 years of related experience in systems engineering of complex medical devices, preferably medical capital equipment, through multiple complete product development life cycles from concept through manufacturing transfer · Minimum of 3 years leading technical project teams through at least one complete product development life cycle · Advanced knowledge of FDA, IEC, electrical standards (UL/ETL) and design controls relating to medical devices
2. Skills and Abilities · In depth understanding of systems engineering, including design of electronic, optical, mechanical, and software systems, specification of requirements, and qualification of components. · Excellent interpersonal, organizational as well as verbal and written communication skills · Strong technical and analytical abilities including DOE and statistical analysis utilizing such tools at Matlab, Mathcad, Minitab, or Excel · Familiarity with high power laser products desirable · Familiarity with optical modeling, fluid dynamics, heat transfer, HV power desirable · Proficiency with Microsoft Windows Office tools and RequisitePro or DOORS · May be six sigma certified
Other:
Company: Corporate Growth Resources
Date: 08/19/2008
Location: Framingham area
State of Job: Massachusetts
Person to Contact: Debbie Rausch
Contact phone or email: corporate.growth@yahoo.com
Title of Job: Mechanical Drafter - temporary
Description:
Work with mechanical engineers to document and detail designs of new subsystems for lasers or update existing subsystems. Generate detail drafting of sheet metal, machined metal, and plastic parts using 3D CAD software. Create 3D assembly drawings for laser systems and subassemblies. Support existing products with Engineering Change Orders. Participate on project teams developing mechanical fixtures for testing and performing testing as required.
All design work will be performed according to all pertinent procedures outlined in the “Corporate Quality Management System” (CQMS).
Requirements:
Requires a minimum of 3 years experience in mechanical drafting/detailing. Working knowledge of SolidWorks CAD software and PDMworks as well as Adobe Writer and Microsoft Office. Experience with the requirements of detailed drafting for the fabrication of sheet metal, machined, and molded components. Familiar with change control in a medical device design and manufacturing environment. Familiar with 3D prototyping (FDM). AS degree in drafting/design preferred.
Other:
Company: Corporate Growth Resources
Date: 08/19/2008
Location: MetroWest
State of Job: Massachusetts
Person to Contact: Debbie Rausch
Contact phone or email: corporate.growth@yahoo.com
Title of Job: Mechanical Engineer - Manufacturing
Description:
Serve as key member of operations team, responsible for the resolution of design and process related issues on electro/mechanical medical devices. Additional responsibilities will include ensuring manufacturability and managing transfer of designs from R&D to manufacturing.
Support transfer of electro-mechanical designs from Engineering to Manufacturing. Review propose mechanical designs to ensure fit with mating part, proper dimensioning and tolerencing and proper manufacturing methods, Identify critical dimensions on custom components Evaluate exiting designs and recommend alternative methods of manufacturing raw materials (i.e. sheet metal, molded plastic components, precision machined parts), to minimize cost while maintaining a high level of mechanical integrity Recommend vendors for raw material, and contribute to technical and quality evaluation audits. Provide guidance to sub-contract capital equipment vendors in the development of inspection processes for mechanical components, assuring efficiency and effectiveness. Travel Required: Estimated travel is 25%, although extended stays may be required to implement processes at contract manufacturer sites.
Requirements:
10 plus years directly related experience, in the medical device industry Bachelor of Science in Mechanical Engineering or significant work experience related to design for manufacturability and GD&T Thorough knowledge of GD&T/ANSI Y14 Intimate familiarity with sheet metal fabrication, injection molding, precision machining and electro/mechanical assembly processes.
Other:
Company: Corporate Growth Resources
Date: 08/18/2008
Location:
State of Job: Massachusetts
Person to Contact: Debbie Rausch
Contact phone or email: corporate.growth@yahoo.com
Title of Job: Senior Optical Mechanical Engineer
Description:
Accountability Objective: – Architect, design and implement laser heads, resonators, optical and opto-mechanical delivery systems for high energy medical lasers (dye, crystal, solid-state). – Perform laser system performance analysis and quantify performance by measurement of beam profiles, energy stability, (thermal and mechanical), pulse width, wavelength, and beam propagation. – Develop manufacturing and quality procedures for designed systems and support manufacturing in pilot builds and trouble-shooting – Support field service with customer issues as required. – Design and implant changes on existing products to improve reliability, reduce cost, and fix problems as required. – Direct the efforts of opto-mechanical engineering resources as needed – Prepare for and participate in comprehensive design reviews – Take on responsibility as technical project lead managing internal as well as external resources.
Requirements:
Knowledge/Educational Requirements: – BS, MS preferred, in Optical Engineering, Mechanical Engineering or Physics – Minimum of 10 years in optical design, preferably with high powered laser optics – Working knowledge of Zemax Ray Tracing program or equivalent – Excellent interpersonal, organizational as well as verbal and written communication skills – Familiarity with high power medical laser products desirable – Familiarity with medical device development – Proficiency with Microsoft Windows Office tools
Other:
Company: Common Agenda
Date: 08/18/2008
Location: Albuquerque
State of Job: Not New England
Person to Contact: Bill Rowe
Contact phone or email: 732-223-7114 x103 or wjrowe@commonagenda.com
Title of Job: Scientist/Analyst – Complex Analytical Applications
Description:
Our client is a dynamic bio-medical device company whose mission is to help the tide of the worldwide diabetes epidemic with the introduction of noninvasive technologies for disease detection and health monitoring. Highly motivated and extremely bright colleagues collaborating in small teams characterize the work environment. The companies highly esteemed scientists and engineers have conducted cutting edge research and development in order to create non-invasive diagnostic tools for medical uses.The company is based in the South West and offers competitive salaries, stock options, excellent benefits and a great work environment.
Common Agenda has been entrusted to conduct a search for a Scientist/Analyst who will work closely with our client’s scientific and engineering teams to design bench and clinical experiments and to evaluate study results, all with the aim of improving the design and performance of commercial devices and algorithms.
Requirements:
Essiential Duties & Responsibilities Ø Experimental characterization of novel optical instrumentation Ø Understanding and mitigating sources of measurement error Ø Development of robust calibration methods
Skills Ø Expertise in numerical analysis, chemometrics and data mining. Ø Experience in noninvasive medical diagnostics or other complex analytical applications is desirable. Ø Demonstrated, applied experience in similar technologies and proficiency with Matlab is essential. Ø Creativity, Persistence and a demonstrated ability to work both independently and with multidisciplinary teams characterize the successful applicant.
Education Ø A degree in applied mathematics, spectroscopy, analytical chemistry or related field.
Other:
Company: Prestige Scientific
Date: 08/15/2008
Location: North Shore
State of Job: Massachusetts
Person to Contact: Shawn Schantz
Contact phone or email: 508-422-9322 sschantz@prestigescientific.com
Title of Job: Quality Engineer
Description:
Medical Device Manufacturer of Disposable Medical Goods is looking for a Senior Quality Engineer to help start up the quality department in this facility.
Requirements:
Candidates must have:
*5+ years of Medical Device Quality Experience
* BS in Science/Engineering
* Experience with Process Validations, Design Controls, Quality Systems and Field Assurance.
Other:
http://recruitershawn.blogspot.com/2008/08/job-openings-week-of-august-4th.html
Company: Nachman BioMedical
Date: 08/11/2008
Location:
State of Job: Massachusetts
Person to Contact: Phil Nachman
Contact phone or email: phil@nachmanbiomedical.com
Title of Job: Senior Quality Assurance Engineer
Description:
Exciting, ground floor opportunity to have a key role assuring the quality of medical devices at an innovative, rapidly growing surgical device company. This well funded organization has developed a unique system used during cardiac surgery procedures, such as angioplasty. This pioneering system delivers and controls cath lab devices during interventional catheterization procedures, a fast growing $7.5B market. This Senior Quality Assurance Engineering opportunity is an ideal situation to join a talented team, at an early stage, and make a real difference using your experience and knowledge, while continuing top learn and develop.
POSITION SUMMARY: The Senior Quality Assurance Engineer will act as a lead technical and system knowledgeable resource in all matters related to the quality and reliability of company product. He or she will be a hands-on leader and participate in all activities involved in the planning, problem resolution, continuous improvement and conformance verification of the design, procurement, manufacture, distribution and customer service of company supplied goods and services. There will be extensive interact with all functions in the company, its suppliers and design consultants. The ideal candidate will utilize his or her extensive knowledge of Quality systems and the accompanying design controls, applied to medical devices. An understanding of SW in motor controls and validation is a plus.
RESPONSIBILITIES: Participate in the installation of the Quality System Review and approve all documentation for accuracy and conformance to the QA system requirements. Write inspection/test/calibration procedures for equipment and product Perform failure analysis Manage the completion of validation protocols and test plans Participate in process and device validation and qualification including software Manage the inspection and MRB process and disposition of material Perform Internal and Supplier audits and follow-up Propose, initiate and follow-up corrective actions
Requirements:
5-10 years experience as a QA Engineer in a medical device manufacturing environment. Experience in other regulated industries using GMP/ISO 13485, military spec, etc. would be considered. BS in an engineering discipline Direct experience in one or more of the following: electro/mechanical devices, motion control electronics, Quality system implementation, injection molding, sterilization, safety testing, design validation and verification. Excellent computer and communications skills
Other:
Well funded, energetic start up, with seasoned industry professionals.
Company: Nachman BioMedical
Date: 08/11/2008
Location:
State of Job: Massachusetts
Person to Contact: Phil Nachman
Contact phone or email: phil@nachmanbiomedical.com
Title of Job: Senior Engineer, Medical Device Delivery Systems
Description:
Senior Engineer, Medical Device Delivery Systems Exciting start up developing best-in-class medical products built upon the pioneering research of its academic founders, and its talented industry veterans. The Senior Engineer, Medical Delivery Systems will report to the VP of Engineering, with overall responsibility for the design and development of the company’s devices for percutaneous delivery of biomaterial constructs. He or she will be a key technical resource for catheter and delivery system engineering,
The successful candidate will be joining a team that is defining a unique and exciting path to a successful future for a medical device company. Working together, they bring world class expertise in organic and polymer chemistry, material science, biophysics, microfluidics, micro- and nanotechnology, cell-surface biochemistry, self-assembly, implantable devices and drug delivery. The company's advances in these varied but related disciplines comprise an expertise in biomaterials science that in turn provides a broad, flexible platform for the rapid development of devices that combine structural and mechanical attributes of traditional medical devices with the biological activity of pharmaceutical agents.
The goals of the Company are far-ranging, and leverage a forward investment in a vision that includes the following elements: • Uniting the required domains of nanotechnology, microfabrication, chemistry, materials science, and biology within one company to create a biomaterials platform for the future. • Culture is critical to the success of the Company. Gathering together chemists, materials scientists, biologists, engineers, business professionals, and clinical advisors unified under one compelling vision and mission. Co-location of these human resources ensures that discipline barriers can be overcome quickly and efficiently to harness the innovation and creativity of Company personnel. • A brand new facility that enables this unification through the use of 27,000 square feet of in-house laboratories that enable first creation of the biomaterials technologies (chemistry and materials science lab), incorporation of these into products (engineering lab), and finally interrogation of the pre-clinical effect (biology, histology and imaging labs). These unique facilities are steps away from the management team, fostering a communicative, collaborative culture.
Key areas of responsibility • Lead efforts to brainstorm concepts and create prototype delivery systems • Generate numerous design concepts, narrow down, and select the best option through an appropriate mix of analysis and prototyping • Direct external and internal resources to achieve on-time development of novel delivery systems; coordinate delivery systems efforts with biomaterials device development • Define and document testing & evaluation of new design concepts • Work within a cross functional team to achieve the project goals and milestones • Consult with R&D Engineers & Scientists; QA; Product Development Engineers; Operations
Requirements:
•BS in Mechanical Engineering, Plastics Engineering or Biomedical Engineering; MS preferred •5-7 or more years of R&D experience in the medical device field; start-up experience is a plus •Successful demonstration of full-cycle product development (concept to commercialization) •Must have the ability to make sound technical decisions, prioritize project timelines, follow up and complete critical items •Knowledge of GMP and QSR; familiarity with Design Controls and ISO guidelines •Documented experience with designing and developing interventional catheter-based delivery systems, including materials, tests and manufacturing processes •Experience with managing external and internal resources to meet accelerated development schedules •Hands on development/prototype ability •Proficiency in 3D CAD design expected (Solid Works preferred) •Highly motivated and enthusiastic team player •Ability to work closely within and/or lead a cross functional development team •Strong communications and interpersonal skills
Other:
Additional opportunities may be viewed at: www.nachmanbiomedical.com
Company: Nachman BioMedical
Date: 08/11/2008
Location:
State of Job: Massachusetts
Person to Contact: Phil Nachman
Contact phone or email: phil@nachmanbiomedical.com
Title of Job: Senior Medical Device R&D Engineer
Description:
Senior Medical Device R&D Engineer – Robotics Exciting, ground floor opportunity to have a key role designing medical devices at an innovative, rapidly growing surgical robotics company. This well funded organization has developed a unique robotic system used during cardiac surgery procedures, such as angioplasty. This pioneering system delivers and controls cath lab devices during interventional catheterization procedures, a fast growing $7.5B market. This Senior R&D Engineering opportunity is an ideal situation to join a talented team, at an early stage, and make a real difference by using your experience and knowledge to shape the company.
POSITION SUMMARY: The Senior R&D Engineer will design the mechanisms and manage the development of projects to commercialize the company’s lead product, as well as subsequent design improvement or next generation projects. The successful candidate will interact with physicians and other industry peers to develop the requirements for the product, and then develop and implement a design. He or she will develop design inputs, write specifications, create and develop mechanisms and designs while directing the implementation of the project to completion. Cross functional communication to get design input, project management skills and hands on capabilities are required for success in this key role. The ideal candidate will have extensive knowledge of mechanical design in plastic molded components and machined parts used in mechanisms as well as motors and control systems. The candidate will be a hands on designer first and foremost and also be able to help manage a cross functional team to complete the project. A working knowledge of medical devices and Quality systems and the accompanying design controls is required. An understanding of software in motor controls and validation is a big plus.
RESPONSIBILITIES: Participate in developing the 1st commercial version of the system - assist in managing the design firm Design and develop the electro-mechanical systems for the next generation product Interact with physicians to develop the design inputs for the next generation product Perform animal studies and bench testing necessary to prove the design Manage design transfer including all testing and documentation required by the Quality system Be the top technical resource in the R&D organization
Requirements:
5-10+ years in R&D design engineering, largely or entirely in a medical device company BS or MS in Mechanical, Plastics, Biomedical Engineering or a relevant discipline Strong experience with electromechanical mechanisms and systems Significant experience designing plastic molded components and machined parts Design and development of robotic devices is a plus Previous success developing products through commercialization Experience as a team leader managing medical devices through the design process Software and its validation a big plus ProE or SolidWorks proficiency
Other:
Additional opportunities may be viewed at: www.nachmanbiomedical.com
Company: Prestige Scientific
Date: 08/06/2008
Location: North Shore
State of Job: Massachusetts
Person to Contact: George Tanen
Contact phone or email: 508-422-9322 / gtanen@prestigescientific.com
Title of Job: Director of Marketing
Description:
Established Medical Device Manufacturer of Implantable Devices is currently looking for a Director of Marketing.
CLient wants someone want someone with strong experience in MarCom and successful product launches.
Requirements:
• Requires a BS or equivalent in business or scientific field, MBA is highly desirable and a minimum of 2 years of strategic marketing experience and 5 years of marketing experience in medical devices business development environment.
Other:
Company: Prestige Scientific
Date: 08/06/2008
Location: North Shore
State of Job: Massachusetts
Person to Contact: Shawn Schantz
Contact phone or email: 508-422-9322 sschantz@prestigescientific.com
Title of Job: Quality Engineer
Description:
Fortune 500 Medical Device Manufacturer is currently looking for a Quality Engineer to join their small and intimate team. We are looking for someone that has just a few years of experience under their belt and wants to flourish within a very small environment.
We need someone with a good background in Quality Engineering, validations and customer interaction.
Requirements:
* 3-5 yrs of Quality Engineering within Medical Device Manufacturing
* BS/MS in Science
* Ability to work independently
Other:
Company: BioScale
Date: 08/05/2008
Location: Cambridge
State of Job: Massachusetts
Person to Contact: JT Rynak
Contact phone or email: jrynak@bioscale.com
Title of Job: Development Engineer - MEMS
Description:
Development Engineer - MEMS
We are looking for a highly resourceful and creative MEMS Engineer to join a team of scientists and engineers focused on the development of BioScale’s proprietary MEMS-based biosensor technology.
Responsibilities:
Work with process engineers to develop MEMS device designs, process flows and packaging methods that meet requirements:
Design new devices. Employ analysis and modeling methods where appropriate. · Work with process engineers to develop process flows and prototype devices. · Characterize device performance, repeatability and reliability. Troubleshoot, identify necessary design changes, and implement solutions. · Assist in the transition of designs to manufacturing. · Contribute to the development of new device designs, process flows and packaging methods. · Model device performance and compare to test results. · Refine existing designs and process flows to meet manufacturing cost and volume goals. · Work with vendors to fabricate prototypes and transition processes to production.
Requirements:
Requirements:
Candidates need to be familiar with MEMS design, fabrication and packaging methods. This position requires a Ph.D. or M.S. in an engineering field and at least 3 years of product development experience.
Strong oral and written communication skills
Interested candidates should forward their CV / Resume to: jrynak@bioscale.com .
BioScale, Inc.
75 Sidney Street
Cambridge, MA 02139
Other:
Company: BioScale
Date: 08/05/2008
Location: Cambridge
State of Job: Massachusetts
Person to Contact: JT Rynak
Contact phone or email: jrynak@bioscale.com
Title of Job: Scientist / Sr Scientist, ImmunoAssay Applications Development
Description:
Scientist / Sr Scientist, ImmunoAssay Applications Development
BioScale is a fast-growing biotechnology company developing a next-generation MEMs-based biosensor tool for research and diagnostics. We are seeking a highly motivated, experienced Sr. Scientist to take a leading role in the development of new immunoassay applications for Industry and Academic research.
Responsibilities:
Lead and coordinate daily activities of a team of scientists working on development of new biosensor immunoassays
Assay design, implementation and optimization
Hands-on participation in immunoassay development
Generate Proof of concept/assay development for academic and industry partners
Support successful completion of academic and industry partner interactions
Requirements:
Experience requirements:
PhD in Biology, Biochemistry, Immunology, or related field.
5 years experience, including 2+ years developing immunoassays in an industry setting.
Experience working in a multidisciplinary environment
Experience developing commercial immunoassay kits preferred
Proven experience leading customer interactions and research collaborations
Prior experience developing biosensor or microparticle-based immunoassays is preferred
Strong oral and written communication skills
Interested candidates should forward their CV / Resume to: jrynak@bioscale.com .
BioScale, Inc.
75 Sidney Street
Cambridge, MA 02139
Other:
Company: BioScale
Date: 08/05/2008
Location: Cambridge
State of Job: Massachusetts
Person to Contact: JT Rynak
Contact phone or email: jrynak@bioscale.com
Title of Job: Software Engineer
Description:
BioScale is a fast-growing biotechnology company developing a next-generation MEMS-based biosensor platform for research and diagnostic applications. We are seeking a highly motivated, experienced software engineer to be a contributor in developing software for our MEMS-based bio-analysis systems. The successful candidate will execute on improvements to the current software implementation. Additional activities include supporting R&D efforts and developing next generation systems.
Responsibilities:
Work with Program Managers and customers to define requirements and develop requirements specifications. Participate in requirements, design, code and test plan reviews.
Demonstrate increasing technical proficiency in program design and implementation.
Utilize Linux internals and the Qt library to build unique software systems and programs.
Develop unit tests and test harnesses.
Work with new product development teams including electrical engineers, mechanical engineers, software engineers, chemists, scientists, marketing, and project leaders in the development of instrumentation.
Support design of instrument user interface and develop simulation tools as required.
Develop new functionality and enhancing current analyzer tool set.
Develop the latest UI using QT (TrollTech).
Develop code, documentation and specifications in accordance with the BioScale’s Software Quality Assurance Plan.
Requirements:
Requirements:
Candidate must have 3+ years embedded development in C/C++, strong Object Orientated background.
Candidate must have strong Linux or Unix background; Linux is preferred.
Candidate should be familiar with UML modeling and MDA (Model Driven Architecture).
Prior experience developing LabVIEW Applications is desired.
Prior experience developing software using Qt (TrollTech) libraries desired.
Strong oral and written communication skills.
Interested candidates should forward their CV / Resume to: jrynak@bioscale.com .
BioScale, Inc.
75 Sidney Street
Cambridge, MA 02139
Other:
Company: Histogenics
Date: 08/05/2008
Location: Waltham
State of Job: Massachusetts
Person to Contact: Robin Caruso
Contact phone or email: rcaruso@histogenics.com
Title of Job: Director of Clinical Operations
Description:
Histogenics, located in Waltham MA is a tissue regeneration company developing breakthrough treatments for long-lasting joint repair. Its cartilage regeneration products apply advanced cell biology, tissue engineering and materials science in the repair of injured or diseased joints, to restore joint function and prevent degenerative disease.
Histogenics is growing and looking for talented individuals to join our team!
POSITION SUMMARY:
Reporting to the Vice President, Regulatory, Clinical and Quality, the incumbent is responsible for development and execution of a strategy to ensure that all clinical study enrollment goals are met, and that clinical operations activities are conducted efficiently and in compliance with US requirements.
MAJOR DUTIES AND RESPONSIBILITIES:
• Develop, implement, and support patient recruitment and retention strategies for clinical studies.
• Develops strategies and field activities to increase productivity and optimize value of clinical projects.
• Oversees strategy for study site feasibility and selection to insure optimal selection of sites and investigators.
• Liaise regularly with clinical investigators, study coordinators, monitors, and other external staff training to ensure timely and quality execution of studies.
• Provides in-service training to surgeons and clinical study staff
• Advises cross functional teams on recruitment methodologies and recruitment metrics.
Requirements:
QUALIFICATIONS:
Work Experience:
• 10 years direct medical device development/clinical study/clinical sales experience
• Experience in developing and implementing metrics and clinical study patient recruitment strategies.
• Experience in identifying solutions to recruitment issues and solving problems arising from recruitment.
• Experience with design and conduct clinical studies and training programs
• Experience developing and tracking appropriate metrics to assess clinical operations performance.
• Experience and comfort in the operating room.
• Familiarity with FDA Requirements.
Skills (Technical Knowledge):
• Proficiency in Microsoft applications
• Strong analytical skills
• Strong training and mentoring skills
Skills (General Knowledge):
• Verbal and Written Skills
• Attention to detail and accuracy
• Ability to interface with multiple disciplines
• Project Management Skills – ability to multi-task
• Planning and Organizational Skills
• Interpersonal Skills – ability to work in a team oriented environment
• Flexibility and Creativity
• Communicates Openly
Education:
• Requires a technical degree in Life Sciences, or equivalent experience
Prior experience in orthopedics, nursing is preferred
This position will require up to 75% domestic travel.
Other:
Company: Histogenics
Date: 08/05/2008
Location: Waltham
State of Job: Massachusetts
Person to Contact: Robin Caruso
Contact phone or email: rcaruso@histogenics.com
Title of Job: Director of Clinical Operations
Description:
Histogenics, located in Waltham MA is a tissue regeneration company developing breakthrough treatments for long-lasting joint repair. Its cartilage regeneration products apply advanced cell biology, tissue engineering and materials science in the repair of injured or diseased joints, to restore joint function and prevent degenerative disease.
Histogenics is growing and looking for talented individuals to join our team!
POSITION SUMMARY:
Reporting to the Vice President, Regulatory, Clinical and Quality, the incumbent is responsible for development and execution of a strategy to ensure that all clinical study enrollment goals are met, and that clinical operations activities are conducted efficiently and in compliance with US requirements.
MAJOR DUTIES AND RESPONSIBILITIES:
• Develop, implement, and support patient recruitment and retention strategies for clinical studies.
• Develops strategies and field activities to increase productivity and optimize value of clinical projects.
• Oversees strategy for study site feasibility and selection to insure optimal selection of sites and investigators.
• Liaise regularly with clinical investigators, study coordinators, monitors, and other external staff training to ensure timely and quality execution of studies.
• Provides in-service training to surgeons and clinical study staff
• Advises cross functional teams on recruitment methodologies and recruitment metrics.
Requirements:
QUALIFICATIONS:
Work Experience:
• 10 years direct medical device development/clinical study/clinical sales experience
• Experience in developing and implementing metrics and clinical study patient recruitment strategies.
• Experience in identifying solutions to recruitment issues and solving problems arising from recruitment.
• Experience with design and conduct clinical studies and training programs
• Experience developing and tracking appropriate metrics to assess clinical operations performance.
• Experience and comfort in the operating room.
• Familiarity with FDA Requirements.
Skills (Technical Knowledge):
• Proficiency in Microsoft applications
• Strong analytical skills
• Strong training and mentoring skills
Skills (General Knowledge):
• Verbal and Written Skills
• Attention to detail and accuracy
• Ability to interface with multiple disciplines
• Project Management Skills – ability to multi-task
• Planning and Organizational Skills
• Interpersonal Skills – ability to work in a team oriented environment
• Flexibility and Creativity
• Communicates Openly
Education:
• Requires a technical degree in Life Sciences, or equivalent experience
Prior experience in orthopedics, nursing is preferred
This position will require up to 75% domestic travel.
Other:
Company: TechUSA, Scientific
Date: 07/31/2008
Location: Rockville, MD
State of Job: Not New England
Person to Contact: Chris Frew
Contact phone or email: cfrew@techusa.net
Title of Job: IVD Clinical/Regulatory Specialist
Description:
We are seeking a highly motivated and talented individual to assist in bringing proprietary technology into the field of clinical in vitro diagnostics (IVD). The candidate will coordinate all clinical evaluations and regulatory activities leading to the successful clearance of new IVD devices.
Duties and Responsibilities include but are not limited to;
- Plan, conduct, and evaluate clinical investigations of IVDs, particularly in the area of infectious disease. - Develop clinical study protocols based on current clinical practices for IVDs. - Coordinate with CROs, consultants and company team members. - Serve as the primary company liaison with the FDA - Identify and qualify study sites, recruit site personnel, and coordinate IRB approval processes. - Travel to study sites to initiate and supervise clinical studies; ensure compliance with all regulatory requirements (GCP, etc). - Monitor clinical studies to ensure protocols are followed, provide study investigators with required resources, identify and resolve study site issues to ensure successful study completion. - Integrate all data and assist in performing statistical analyses; assist in preparing 510(k) regulatory submission paperwork. - Stay current on all regulatory aspects; attend professional society meetings.
Requirements:
Knowledge and Experience:
- Minimum 3 years experience in the medical device or pharmaceutical industry, with practical experience in clinical studies. - Experience with 510(k) regulatory submissions, preferably with IVDs. - Excellent written and verbal communication skills with strong English language ability. - Working knowledge of databases (Excel, Access) and statistics.
Other:
Please apply with your resume and let us know what the best way to contact you is. A recruiter will then be in contact with you shortly. Thank you for your interest in our organization.
Company: TechUSA, Scientific
Date: 07/31/2008
Location: Rockville, MD
State of Job: Not New England
Person to Contact: Chris Frew
Contact phone or email: cfrew@techusa.net
Title of Job: IVD Documentation Specialist III/IV
Description:
The incumbent facilitates the development, maintenance, and archiving of documents that capture the research, development, and transfer activities of R&D. The IVD Documenatation Specialist relies on a combination of biomedical education, IVD/Class III medical device develoment regulations, processes, and labeling requirements, and technical writing expertise to help design deparmental templates, create and maintain SOP's, edit protocols and reports, develop/draft manufacturing documents, and develop and maintain end-user labeling. The candidate works directly with R&D staff to gather and document relevant data. Reports to the Manager of Technical Publications/Knowledge Management, R&D.
Requirements:
Minimum requirements include a Bachelor's degree with a minimum of 8 years work-related experience, or MS or Ph.D. with a minimum of 5 year or work-related experience. Education must be in either microbiology, biomedical science, or a related life science. Work related experience must be in an FDA- regulated industry (i.e., medical device or pharmaceutical).
Solid knowledge of information-development priciples and technical publications industry practices and standards. Extensive knowledge of and experience complying with FDA quality systems and labeling regulations (21 CFR 820). Excellent technical writing and editing skills.
Other:
Please apply with a copy of your resume and identify the best way to reach you. A recruiter will then be in contact with you within 48 hours. Thank you for your interest in our organization
Company: Prestige Scientific
Date: 07/10/2008
Location: Boston
State of Job: Massachusetts
Person to Contact: Shawn Schantz
Contact phone or email: 508-422-9322 sschantz@prestigescientific.com
Title of Job: Quality Assurance Director
Description:
Dynamic Medical Device Start up is currently looking for a Director of Quality to head up the department and start staffing as the company/department grows.
Requirements:
* 7+ years in Quality Engineering within Medical Device Manufacturing * Currently be at a Manager/Director level * Currently live in the local market This is a great opportunity for someone to take a department from infancy and help it grow into something phenomenal
Other:
Company: Management Recruiters of Myrtle Beach, Inc.
Date: 07/24/2008
Location:
State of Job: Other New England
Person to Contact: Lori Rowe
Contact phone or email: lori@jobquestsite.com
Title of Job: Quality System Document Control- Pharma/Med Device
Description:
PLEASE NOTE: Your resume will not be properly formatted if you respond to this posting via monster board or another job board. To properly respond, you should format your resume in MS Word or Corel WordPerfect and send it to lar4062@jobquestsite.com as an attachment.
DESCRIPTION: Create and maintain the Corporate Quality Documents and track, approval and implementation at the Manufacturing and Distribution Divisions of this Fortune 500 company. Develop, administer and improve the corporate document management program encompassing SOPs and other controlled documents. This system includes revision control, tracking and archival. This position carries the responsibility of auditing corporate and site documents to ensure compliance and training users on the system. Must track and develop process flow charts, assist with preparation of divisional quality system metrics. This is a great opportunity with one of the best medical device companies specializing in instrumentation, orthopaedic and neurologic devices.
KEYWORDS: QA, pharmaceuticals, medical devices, quality, document control, management systems, doc, SOP, QSM, AQC
LOCATION: Depending on your location- to be discussed
COMPENSATION: High: $112,000.00 with $5k Sign On Bonus Low: $92,000.00
Requirements:
REQUIREMENTS: 5 years of increasing responsibility in a Quality role, BS/BA in life science or related field, experience with Document Management/Control, experience writing quality system documents and implementing quality management
Other:
Company: Management Recruiters of Myrtle Beach, Inc.
Date: 07/24/2008
Location:
State of Job: Other New England
Person to Contact: Lori Rowe
Contact phone or email: lori@jobquestsite.com
Title of Job: Quality System Analyst-CAPA- Pharma/Med Device
Description:
PLEASE NOTE: Your resume will not be properly formatted if you respond to this posting via monster board or another job board. To properly respond, you should format your resume in MS Word or Corel WordPerfect and send it to lar4062@jobquestsite.com as an attachment.
DESCRIPTION: Quality System Analyst will monitor and audit the CAPA activity of site/divisional/corporate applications of SOPs of this Fortune 500 company. Looking for an analytical professional with strong communication skills and a comprehensive understanding of corrective & preventative action within quality systems. This position carries the responsibility of development and training on CAPA and Root cause investigations. Must provide recommendations to site/divisional personnel, assess efficiencies and effectiveness of action plan. This is a great opportunity with one of the best medical device companies specializing in instrumentation, orthopaedic and neurologic devices.
KEYWORDS: QA, pharmaceuticals, medical devices, quality, root cause, corrective and preventative action, SOP, QSM, AQC LOCATION: Depending on your location- to be discussed
COMPENSATION: High: $78,000.00 with $5k Sign On Bonus Low: $68,000.00
Requirements:
REQUIREMENTS: 5 years of increasing responsibility in a Quality role, BS/BA in life science or related field, experience with CAPA systems and root cause analysis
Other:
Company: iPlaceUSA
Date: 07/24/2008
Location: Pittsburgh, PA
State of Job:
Person to Contact: Vasundhara Andalgaonkar
Contact phone or email: vasundhara@iplaceusa.com
Title of Job: Design Varification & Validation Engineer_1911
Description:
• Responsible for analyzing and verifying and validating product requirements of designs and testing the products at various levels to ensure that the products meet the requirements and intended uses of the patient and care provider. • Analyzing product and sub-system requirements. • Writing detailed test procedures that evaluate medical devices and systems against documented mechanical, electrical and software requirements. • Analyzing and verifying medical device designs. • Process control systems involving air flow from device to patient: motors, blowers, pressure and flow sensors, complex software algorithms, masks. • Instrumentation and test of pneumatic circuits, electrical signals, sound and various physical/environmental characteristics. • Familiarity with Active Servo Lungs and Michigan Lung simulators. • Electrical, mechanical, and software sub-systems and inter-relationships. • Working knowledge of SA/QA methodologies and processes and various types of testing. • Good lab practices, including maintaining and controlling test execution records. • Technical writing, including development of test reports.
Requirements:
• Technical writing, including development of test reports. • Develop LabVIEW applications to evaluate the performance of medical devices during the development cycle. • Test automation and management tools, such as Test Director. • Experience working in disciplined, regulated industries; medical device experience preferred, including FDA's 21 CFR 820/ISO 13485 experience. • Experience with 14971 (risk management) and ISO 62304 (software) standards. • Experience with IEC 60601 series of Medical Equipment Standards. • V&V experience in medical device or similar regulated industry; requires.
Other:
Company: iPlaceUSA
Date: 07/24/2008
Location: Pittsburgh, PA
State of Job:
Person to Contact: Vasundhara Andalgaonkar
Contact phone or email: vasundhara@iplaceusa.com
Title of Job: Senior Supplier Quality Assurance Engineer_1971
Description:
• Apply data driven analysis and systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Drive/Lead advanced quality planning and production part approval process for assigned commodities. • Plan and execute equipment qualification and process validation. • Ensure compliance to purchasing controls processes, regulatory, and external standards. • Team cross-functionally to ensure DFx (DFMA: Design for Manufacture & Assembly), Test, Service. • Coordinate test development activities to ensure electronic assemblies meet customer requirements (e.g., drive test correlation between component level and system level performance). • Administer supplier corrective/preventative actions in a timely and effective manner. • Lead supplier process capability programs for new components, processes, assemblies or purchased finished goods. • Drive Continuous improvement at suppliers by managing defined quality initiatives. • Lead Supplier audits to ensure conformity to contractual requirements as well as quality system compliance. • Perform Quality Systems and Process Audits of current suppliers including reporting, follow-up and closure of nonconformance.
Requirements:
We need the following criteria as close as possible. Ø 1-3 years of supplier quality engineer minimum Ø 3-8 years of supplier quality engineering preferred. *medical device or iso 13485 most preferred Ø Electrical Engineer or Mechanical Engineer degrees preferred. Ø Experience in leading suppliers to lower ppms. (ppm is part per million defects) Ø Willing to Relocate.
Other:
Company: iPlaceUSA
Date: 07/24/2008
Location: Pittsburgh, PA
State of Job:
Person to Contact: Vasundhara Andalgaonkar
Contact phone or email: vasundhara@iplaceusa.com
Title of Job: Quality Assurance Engineer_1864BR
Description:
• The Quality Engineer will investigate internal and external quality issues, develop corrective action plans, conduct internal audits and quality system training and use statistical tools for continuous improvement projects. • Investigate internal and external failures. Emphasis will on external failures. • Generate trending reports regarding internal and external failures. • Initiate CAPA's as necessary to support failure analysis. • Recommend updates to Risk Management documents when failure information identifies an undocumented risk. • Make recommendations for design and process changes to reduce internal and external failures. • Conduct design of experiments. • Provide Quality System training • Conduct internal quality system audits. • Generate quality plans. • Update SAP databases with investigation information.
Requirements:
• Three years experience as a Quality Engineer or in a related field working in a manufacturing or engineering environment. Prefer experience with medical devices. Prefer experience with reliability prediction. • The successful candidate will be able to analyze and solve internal and external quality issues. • The investigation will routinely provide information for the CAPA and Risk Management system. • Will work with associates in the Quality, Engineering, Manufacturing and Service teams to reduce the external failure component cost of the Cost of Non Quality program. • Will conduct internal and external audits and conduct quality oriented training classes. • The successful candidate will develop an expert understanding of regulations governing medical devices such as the QSR's, ISO 9000, ISO 13485, CMDR and the MDD.
Other:
Company: iPlaceUSA
Date: 07/24/2008
Location: Pittsburgh, PA
State of Job:
Person to Contact: Vasundhara Andalgaonkar
Contact phone or email: vasundhara@iplaceusa.com
Title of Job: Design Quality Engineer
Description:
• Work in support of product commercialization by serving as QA department's representative on organizational development teams. • Participate in organizational design activities including FMEAs, FTAs, validation development and auditing. • Support Product Design changes throughout the life of the product. Assure changes comply with Design Control requirements. • Responsible for developing and or reviewing key design documentation including; quality assurance plans, design reviews, design verification and validation plans, and t | 