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Manufacturing Engineer at GPAC

Manufacturing Engineer

GPAC Hudson, MA Full-Time
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Medical Device Manufacturing

Position Overview:

The candidate will be responsible for manufacturing and sustaining engineering for a complex electro-mechanical/ optical medical device that is manufactured in a controlled environment. Efforts will focus on improving and/or developing processes, tooling and fixtures for existing products or new products. Candidate will provide leadership, interface, and support for peers in other departments including Quality, Supply Chain, R&D, and Finance.

Essential Duties & Responsibilities:

  • Work with manager and team members to learn products and their associated manufacturing requirements in order to support manufacturing personnel and processes.
  • Understand the user needs and requirements for existing products and processes and update them as needed to improve quality, reduce cost to manufacture, and address obsolescence and regulatory changes.
  • Lead and participate in cross-functional teams.
  • Provide training, direction and manufacturing support for a team of Manufacturing Group Leaders, Assemblers, Engineers, and Technicians.
  • Work with Manager to assure efforts are in full compliance with company Quality policies, ISO and other relevant regulations, company SOP’s and manufacturing procedures.
  • Prepare quality system documentation such as Engineering Change Notifications, Non-Conforming Material Reports, test protocols and reports, process FMEAs and process maps to support operations and Regulatory submissions.
  • Provide leadership and support for manufacturing, sales and quality regarding complaint resolution, product testing, CAPA investigations, and product documentation reviews (specifically including Manufacturing Procedures).
  • Set up standard and special purpose laboratory equipment to test and evaluate devices at different stages of assembly.
  • Formulate tests, calibrations and procedures to maintain precision accuracy of devices.
  • Observe all safety and security procedures; report and manage potentially unsafe conditions, specifically in and around manufacturing areas.
  • Communicate regularly to Engineering Manager and other stakeholders regarding the status of issues and projects.
  • Additional tasks and responsibilities as assigned.

Minimum Qualifications:

  • Bachelor’s Degree in Electrical, Mechanical or Biomedical Engineering.
  • Five years engineering experience in a medical device manufacturing environment. Catheter experience preferred.
  • Solid knowledge of QSR, ISO 13485, and the MDD is highly desired.
  • Familiarity with LEAN principles preferred.
  • Must have ability to read, understand, and develop SOP’s, engineering drawings, and manufacturing procedures.
  • Candidate must speak and understand English effectively.
  • Excellent communication skills (verbal and written) required.
  • Ability to collect, collate, and present data effectively. Grasp of statistical techniques a plus.

If interested please apply or submit 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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