Project Engineer
Core
Lead mechanical design and project management for medical device implants and instruments, ensuring FDA compliance and translating surgeon feedback into tangible solutions.
Role type
Senior IC mechanical design project engineer (medical devices)
Builds
Surgical implants, instruments, and related manufacturing processes for musculoskeletal disorder patients
Domain
Medical technology / Orthopedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mechanical design engineering, Pro/E (CAD), GD&T, risk analysis, project planning, FDA regulatory compliance, budget management, market research
Preferred skills
biomedical engineering background, experience with rapid prototyping, knowledge of MedTech/AdvaMed codes
Technologies
Pro/E, Microsoft Office
Responsibilities
Obtain market feedback from surgeons to define design specifications; create and maintain FDA compliant Design history Files (DHF); manage project timelines and regulatory compliance; design and develop instruments and implants using CAD; coordinate with prototype shops and vendors; perform design verification and validation; assist in writing regulatory applications; coordinate manufacturing setup; participate in product introductions and sales training; monitor post-introduction performance; research industry competitors.
Seniority
Mid-level, hands-on IC