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[full-time] Design Assurance Quality Engineer at Proven Process Medical Devices, Inc.

2012-01-31 15:18:20

Location: South of Boston
URL: http://www.provenprocess.com

Description:

Overview:

The Design Assurance Quality Engineer will work on new product development and improvement teams by qualifying new suppliers, communicating quality/compliance requirements, developing procedures, creating planning documents, approving specifications and providing technical transfer/validation support.

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[full-time] Mechanical Engineer at Proven Process Medical Devices

2012-01-31 12:23:25

Location: South of Boston
URL: http://www.provenprocess.com

Description:

JOB DESCRIPTION FOR A MECHANICAL ENGINEER Overview: The Mechanical Engineer will work with other personnel to design and characterize innovative medical devices, and assist with product testing and validation. Along with management and engineering staff, the Mechanical Engineer will be responsible for various aspects of product development including mechanical design, materials procurement, feasibility hardware fabrication, and development and execution of characterization testing. Product validation activities will include test protocol development, participation in product testing, and test report preparation.

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[full-time] Program Manager at Sunrise Labs, Inc.

2012-01-23 14:21:21

Location: New Hampshire
URL: http://www.sunriselabs.com

Description:

Sunrise Labs is seeking a medical product development program manager with experience in implementing and leading electrical hardware and software/firmware projects from concept to production.

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[full-time] Sr Analog Engineer at Connected Systems

2012-01-11 14:50:39

Location: North of Boston
Description:

Our client north of Boston along route 93 has a perm opening for a Sr Analog Engineer with a background in medical device.

Additional Details available upon request

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[freelance] Administrative Assistant/Event Manager at MedDev Group, Inc.

2012-01-06 14:04:14

Location: Massachusetts
URL: http://www.meddevgroup.org

Description:

MedDev Group has an immediate opening for an Administrative Assistant/Event Manager. Under general direction of membership chair, chair and director of marketing and treasurer, successful candidate will co-ordinate preparation, logistics, on-site administration, reporting and communication of the organization’s programs. Current programs include monthly forum, networking and special interest group (SIG) meetings. Most of our current programs are held week day evenings. Current venues are Bay Colony Corporate Center in Waltham and Rebecca’s Café, Grove Street, Newton, MA. Successful candidate must be available to work during necessary hours for all programs and at designated current and new program venues, if any, in future.

This is an excellent opportunity for someone with superior people skills, strong attention to detail and a working knowledge of computer applications.

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[freelance] Microprocessor Programmer at confidential

2011-12-21 14:06:14

Location: South of Boston
Description:

Startup seeking experienced C programmer who can program a real time microprocessor in a medical device.

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[full-time] Sr. Mechanical Engineer - Scroll Pumps at S3 Associates

2011-12-16 13:04:46

Location: Metro West Boston
URL: http://www.s3-associates.com

Description:

As a key member of the design team you will put your machinery design experience to work developing the latest generation, high performance, dry vacuum pumps. The successful candidate will have the following responsibilities. · Apply Mechanical Engineering fundamental practices in the design of new scroll pumps to achieve product development goals for product performance, cost and schedule.· Perform laboratory testing on prototype systems and sub-systems to validate your design. Direct the work of engineering technicians and junior engineers to perform lab testing using data acquisition systems, and document test results.· Work with Production and Service to troubleshoot problems that arise in production and participate in developing solutions. Generate and implement ECOs and write procedures to resolve those issues.· Liaise with Marketing Product Managers to gather Alpha and Beta site data. Qualifications · BSME required or equivalent relevant experience listed below. MS preferred· Minimum of 9 years experience in the design and development of machinery. · Extensive knowledge of mechanical system design and machine design required.· Ability to perform computations with reasonable speed and accuracy.· Knowledge and experience in using GD&T in designing components and assemblies.· Knowledge and experience selecting engineering materials for a range of applications. · Knowledge of manufacturing processes such as machining, welding, brazing, & mechanical assembly which translates to an understanding of dimensional tolerances and surface finishes achievable with various manufacturing technologies. · Design experience with rotary positive displacement equipment, such as pumps or compressors, highly preferred.· High degree of competence using solids-modeling engineering software, such as SolidWorks preferred. Ability to generate effective 2D drawings for use in the supply chain desired. Competence utilizing FEA software, such as CosmosWorks, for thermal and stress analysis desired. · Ability to perform tolerance analysis for a complex mechanical system preferred. Position is located in the greater Boston Area and limited relocation assistance is available.

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[full-time] Key Account Manager (Medical) at Adecco Engineering & Technical

2011-12-14 12:11:15

Location: Massachusetts
Description:

We are looking for a senior business development professional to lead the our relationship with 2-3 of our Key Accounts in the medical sector, with an emphasis on the surgical sector. These accounts are critical to the success of the business and the successful candidate will need to convince us of their excellence in relationship management and closing business at VP-level, and of their existing bonds with the accounts in question. Account Management is the core of our business development approach in the medical products sector. We have built relationships with senior executives in a select number of Fortune 500 firms with whom we have an enduring relationship. These accounts value our excellence in innovation and particular depth in technology, user centred design and product development.

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[full-time] Business Development Professional – Medical at Adecco Engineering & Technical

2011-12-14 12:05:36

Location: Massachusetts
Description:

We are fully committed to developing our business and seek a US-based sales professional to identify and develop product development and business/technology consulting opportunities throughout the US market primarily focusing on selling our broad range of services to the medical sector. The successful individual will work from our US headquarters in Cambridge, MA. Our Medical Sector clients include medical device, diagnostic and pharmaceutical companies. Key areas include:

Diagnostics
Drug Delivery
Critical Care
Surgical

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[full-time] Sr. Regulatory Affairs Specialist at Davis IT&Engineering

2011-12-06 06:18:42

Location: Greater Boston
Description:

Davis Engineering is a niche staffing firm specializing in the placement of Engineering professionals across New England. We currently have a need for a Sr. Regulatory Affairs Specialist with experience working in a class III medical device manufacturing environment. If interested in this position, please send your resume in a Word Document. Thank you for your consideration.

POSITION OVERVIEW
Experience mid-level leadership position which integrates regulatory knowledge
throughout the product lifecycle with aspects of effective project management and
strategy. The position supports the Regulatory Affairs function by leading the
coordination and preparation of global regulatory premarket submissions.

JOB RESPONSIBILITIES
1. Lead product family focused team of Regulatory Associate(s) and or Specialist(s)
utilizing strong technical regulatory skills in developing strategies for complex projects
and issue.
2. Assist in the mentoring and development of Regulatory Affairs Associates and
Specialists as required.
3. Participate on multidisciplinary teams and communicate regulatory requirements
effectively.
4. Provide regulatory input to product lifecycle planning.
5. Conduct appropriate research to develop strong regulatory strategies for new
products.
6. Determine issues which may create regulatory obstacles and investigate solutions.
7. Negotiate and interact with regulatory authorities during the development and review
process to ensure submission approval.
8. Oversee the organization and preparation of high quality regulatory submissions
9. Oversee preparation and submission of applicable regulatory reports as required.
10. Participate in risk management assessments.
11. Evaluate regulatory impact of proposed design and manufacturing changes to
commercially distributed medical devices.
12. Review and approve product labeling, advertising, and promotional information.
13. Assist in regulatory due diligence process.
14. Lead departmental SOP development and implementation.
15. Maintain electronic and paper regulatory files as required by departmental
procedure.
16. Monitor impact of changing evolving global regulations on submissions, practices
and procedures and communicate to internal stakeholders.
17. Adhere to and ensure the compliance of our Code of Ethics, all Company
policies, rules, procedures and housekeeping standards.

EDUCATION/EXPERIENCE REQUIREMENTS
• Bachelor’s degree in scientific discipline such as life sciences or engineering.
Equivalent experience may be acceptable in lieu of a degree.
• Minimum 5 years Medical Device Regulatory Affairs experience with
demonstrated leadership skills. RAC certification expected. Class Three
Medical Device
• Ability to apply business and Regulatory Affairs ethical standards; analytical
and critical thinking skills
• Strong verbal and writing communication skills; demonstrated leadership
skills
• Ability to manage multiple projects and meet deadlines.
• Proficient in MS Word, Excel, Power Point, and Outlook required.

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