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Project Engineer; Mechanical
Job in
Redwood City, San Mateo County, California, 94061, USA
Listed on 2026-07-25
Listing for:
BioTalent
Full Time
position Listed on 2026-07-25
Job specializations:
-
Engineering
Mechanical Engineer, Product Engineer
Job Description & How to Apply Below
We're hiring a Mechanical Project Engineer to design and develop mechanical components and assemblies for Class III implantable neuromodulation systems and related external accessories.
What you'll do:- Design mechanical components, assemblies, prototypes, and test fixtures for implantable devices
- Perform solid modeling, tolerance stack analysis, and GD&T-based design
- Work with vendors on prototyping and manufacturability
- Design and run mechanical tests, investigate failure modes, and drive design changes
- Support FDA/ISO compliant development, including ECOs, V&V, and design documentation
- Collaborate with electrical, firmware, systems, quality, and regulatory teams
- Work directly with physicians and clinicians to translate feedback into design requirements
- Contribute to early-stage concept development and IP generation
- Support risk management activities including hazard analysis and FMEA
- Bachelor's degree with 3-5 years of medical device development & verification experience (Complex Class II, or Class III exposure preferred)
- Strong background in tolerance stack analysis, solid modeling, and GD&T
- FEA, fatigue testing, and biomedical materials experience preferred
- Familiarity with injection molding, welding, and implantable device manufacturing methods
- Experience with usability studies and cadaver study feedback
- Strong communication skills and ability to influence cross-functional decisions
- Willingness to travel ~10% domestically and internationally
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