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.
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