Related skills
solidworks electromechanical fda 510(k)📋 Description
- Lead mechanical design and reviews; manage schedules and tech requirements.
- Design high-fidelity prototypes for usability studies and requirements.
- Define testing plans; create custom test methods and fixtures.
- Support design control docs; lead ECOs to maintain documentation.
- Drive manufacturing transfers; partner with production for improvements.
- Diagnose and support QMS; handle NCMRs/CAPAs for mechanical design.
🎯 Requirements
- 5+ years mechanical engineering; electromechanical systems.
- Class II medical device development; design to FDA 510(k) and manufacturing.
- DFM mindset; plastics, silicone molding, machining, PCB fabrication, 3D printing.
- SolidWorks expert; complex surfacing, manufacturability, tolerancing.
- Regulatory knowledge: IEC 60601-1 and ISO 10993.
- Quality/risk: phase-gate, risk analysis, design controls, root-cause; GD&T/DOE.
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