Manufacturing Engineer – Medical Devices

Solid career opportunity with an expanding developer and manufacturer of lifesaving Class 2 and 3 medical devices. The Manufacturing Engineer will be a hands-on leader supporting new product transfers and launches, developing manufacturing protocols, and creating improvements in the production of current products, in an FDA, GMP environment.

We seek a well-organized manufacturing engineer with strong communications skills and leadership potential, who is motivated to join a team of accomplished medical device managers and staff.

Essential Tasks:

  • Identify and lead medical device manufacturing cost and quality improvement projects.
  • Manage a variety of manufacturing engineering projects.
  • Introduce and manage design changes and projects on the production floor, and instruct assemblers in build protocols and techniques.
  • Support new product transfer activities including production and inspection procedures.
  • Perform and/or support risk assessment and supplier qualifications, process V&V, and updates to label, mechanical drawing, and BOMs.
  • Investigate, analyze and resolve production related product performance problems.
  • Support nonconformance investigations and CAPAs.
  • Work effectively with Systems Engineers, Product Development Engineers, and Software Engineers to report and rectify reliability issues.

Qualifications/ Experience:

  • BS or MS in engineering or science.
  • Two – Five years’ manufacturing engineering experience, in industry, ideally medical devices.
  • Demonstrable experience transferring products from R&D, implementing design changes on the production floor, managing manufacturing projects, and supporting existing products.
  • Experience in smaller, agile high growth organizations with aggressive timelines.
  • Excellent communications skills and the ability to thrive in a collaborate, team environment.

Apply for this position