Development Sr Engineer II
$100k - $124kZimmer Biomet
Zimmer Biomet seeks a Senior Development Engineer II in San Diego to lead medical device design, development, and commercialization for orthopedic products. The role involves translating clinical user needs into compliant designs, managing cross-functional teams, and supporting regulatory and manufacturing processes.
Responsibilities
- Lead new product design and development from concept through commercialization as design owner or project manager
- Engage with orthopedic surgeons and clinical users to identify needs and translate into design requirements
- Create design documentation, rationale, and patent disclosures; develop product production specifications
- Execute design verification, validation, and process validation activities including testing and cadaveric evaluations
- Support quality, regulatory, manufacturing, and clinical affairs teams in product development and regulatory submission processes
Requirements
- Bachelor's degree in mechanical, biomedical, aerospace, or related engineering discipline from ABET-accredited program
- 5-7 years of medical device product design and development experience
- Proficiency with parametric CAD modeling (NX Unigraphics preferred) and finite element analysis software
- Working knowledge of FDA QSR, EU MDR regulations, and industry technical standards
- Understanding of manufacturing processes (machining, molding, additive manufacturing, casting, forging) and material science
- Demonstrated statistical knowledge including design of experiments and hypothesis testing
Compensation: $100,000-$124,000 base per year plus performance bonuses
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