Role OverviewThe Senior Mechanical Design Engineer is responsible for independently leading and executing mechanical design and development activities for new and existing medical device products. This position applies advanced mechanical engineering expertise to the design, development, verification, and lifecycle support of high-reliability critical care medical devices.
What You Will Do
Lead and execute mechanical design and development activities for medical device components, assemblies, and systems using SolidWorks and established engineering methodologies. Develop and maintain mechanical engineering documentation throughout the product lifecycle, including design specifications, drawings, engineering analyses, design reviews, change orders, and Design History File (DHF) records.
Why It Might Be a Fit
The ideal candidate will have 7+ years of progressive mechanical engineering design and development experience, including experience designing and developing products within the medical device or other highly regulated industry. Strong knowledge of design for manufacturability (DFM), tolerance analysis, and GD&T principles is required.
Requirements
- Bachelor's degree in mechanical engineering or a related engineering discipline
- 7+ years of progressive mechanical engineering design and development experience
- 5+ years of hands-on experience with SolidWorks or comparable 3D CAD software
- Demonstrated experience in mechanical design of Plastic and Pneumatic components for use in Class 2 medical devices
- Working knowledge of FDA medical device requirements, ISO and IEC standards, and applicable quality system requirements
Benefits
- Annual base salary of $120,000 to $150,000
- Opportunity to work on high-reliability critical care medical devices
- Chance to develop and execute mechanical engineering verification testing
- Support for regulatory documentation and submissions, including 510(k) submissions
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