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Senior Manufacturing Engineer Medical Device at GPAC

Senior Manufacturing Engineer Medical Device

GPAC Marlborough, MA Full-Time
$90,000 - $120,000/Year
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Medical Device Manufacturing Industry

Position Overview:

The candidate will be responsible for technical and Operations support to a team of Group Leaders, Assemblers, and Engineers/Technicians in a controlled manufacturing environment. Efforts will focus on designing and developing equipment, tooling, fixtures, and/or processes required for new products, product changes and enhancements that will support product throughput and quality goals. Candidate will provide leadership, interface, and support for peers in other departments including Quality, Materials Management, R&D, and Finance.

Essential Duties & Responsibilities:

  • Providing training, direction and manufacturing support for a team comprising of Group Leaders, Manufacturing Assemblers and Engineers/Technicians.
  • Working with Manufacturing Manager to assure the team’s efforts are in full compliance with company Quality policies, ISO and other relevant regulations, company SOP’s and manufacturing procedures.
  • Understanding and interpreting engineering and production drawings and procedures.
  • Training assemblers to production drawings and procedures in the following areas-
  • Assembling components into complex sub-assemblies.
  • Performing intermediate assembly tasks such as trimming, polishing, sanding, cleaning, bonding, curing, etc.
  • Packaging products in preparation for sterilization processing.
  • Working directly with Manufacturing Manager and Associate Engineer to collect and analyze relevant process data. Use data to identify, explore, and implement process improvements.
  • Working with R&D Engineers to support, ensuring manufacturability and a smooth transition from R&D into Manufacturing of new product initiatives.
  • Preparing documentation including NCMR’s, ECN’s, Manufacturing Waivers, etc. in support of assembly, packaging, and sterilization operations.
  • Providing leadership and support for manufacturing, sales and quality with regard to complaint resolution, product testing, CAPA investigations and product documentation reviews.
  • Setting up standard and special purpose laboratory equipment to test and evaluate devices at different stages of assembly.
  • Formulating tests, calibrations and procedures to maintain precision accuracy of devices.
  • Communicating daily to VP Operations all pertinent manufacturing process, quality, or technical activities including process improvement, equipment and/or material issues.

 Minimum Qualifications:

  • Bachelor’s Degree in an Engineering discipline preferred. Significant applicable experience may be considered in lieu of degree.
  • Minimum of seven years’ engineering experience in a regulated medical device manufacturing environment.
  • Solid knowledge of QSR, ISO 13485, and the MDD is critical.
  • Familiarity of LEAN principles preferred.
  • Must have ability to read and understand SOP’s, engineering drawings, and manufacturing procedures.
  • Basic machine shop skills a plus.
  • Candidate must speak and understand English effectively.
  • Excellent communication skills (verbal and written) required.
  • Ability to collect, collate, and present data effectively.

If interested please apply, or send resume confidentially to

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

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