Mechanical Engineer

Mechanical Failure Investigation Engineer / Quality Engineer to perform testing and documentation for disposable medical devices. The ideal candidate will have a BSME and strong failure and thermal analysis experience. Prior experience in the medical device industry (preferably disposables) and work with FDA regulations is a big plus but not required. Strong testing and documentation skills required. Contract-to-perm or permanent opportunity with a medical device company in the North Shore area of Boston, MA.

RESPONSIBILITIES

- Address field complaints by determining root cause and implement corrective actions
- Perform mechanical, fluid, vibration and thermal analyses to support and improve existing products
- Fabricate prototypes with assistance from technical support team (Machine Shop, Technicians and Designers) and suppliers
- Contribute to test methods and conduct characterization and engineering pre-verification testing
- Assist in writing test protocols and reports for process/design changes on existing product lines

REQUIREMENTS

- 5+ years mechanical engineering, design, testing, and analysis with strong thermal, reliability, structural, fluid, etc, analysis experience including failure investigation
- FDA Regulation knowledge and experience in the medical device industry is preferred. Disposable medical device experience is a BIG plus
- Working knowledge of polymers, adhesives and their manufacturing processes
- BS in Mechanical Engineering or equivalent relative work experience
- Excellent writing skills to document failure analyses
- Excellent troubleshooting skills