Senior Project Engineer
Core
Leading product development for medical implants and surgical instruments by managing projects from design specification to regulatory submission and manufacturing setup.
Role type
Senior Project Engineer (Medical Devices)
Builds
New surgical instruments, implants, and related manufacturing processes for musculoskeletal disorder treatments.
Domain
Medical Technology / Orthopedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design engineering, project management, regulatory compliance (FDA), Creo software, rapid prototyping coordination, market research, budget preparation
Preferred skills
Medical device industry experience, leadership of engineering teams, stakeholder management with surgeons and vendors
Technologies
Creo, Microsoft Office
Responsibilities
Obtain market feedback to define functional specifications; create and maintain FDA Design History Files; manage project timelines and regulatory compliance; design and develop instruments and implants; partner with prototype shops for rapid prototyping; perform design verification and validation; assist in writing regulatory applications; partner with operations to setup manufacturing; participate in product introductions and sales training; monitor post-introduction customer requests; research industry competitors.
Seniority
Senior, hands-on IC with leadership responsibilities