Project Engineer
Core
Lead mechanical design and project management for medical device implants and instruments, translating surgeon feedback into compliant, market-ready 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, FDA Design History File (DHF) creation, Pro/E software proficiency, project planning and budget management, regulatory application writing, rapid prototyping coordination, market research, manufacturing setup
Preferred skills
medical device experience, ability to attend surgeries and labs
Technologies
Pro/E, Microsoft Office
Responsibilities
Obtain market feedback from surgeons to define functional and design specifications; Create and maintain FDA-compliant Design History Files; Manage project timelines and ensure compliance with quality systems; Design and develop instruments and implants; Partner with prototype shops and vendors for rapid prototyping; Perform design verification and validation; Collaborate on market forecasts and regulatory applications; Partner with operations to setup manufacturing and purchasing; Participate in product introductions via sales training and customer visits; Monitor post-introduction performance and customer requests; Research industry competitors to ensure cutting-edge technology.
Seniority
Mid-level, hands-on IC