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.
- 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.
- 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.