Project Engineer, Development
Core
Lead the development of medical instruments and implants for patients with musculoskeletal disorders, translating clinical insights into tangible surgical solutions.
Role type
Senior mechanical design engineer (medical devices)
Builds
Surgical instruments and implants for orthopedic procedures
Domain
Medical technology / Orthopedics
Deliverable
production ML models | product features
Required skills
Mechanical design engineering, Creo Parametric (CAD), FDA Design History File (DHF) creation, regulatory application writing, project management, market research, manufacturing setup, sales training
Preferred skills
Experience in medical device field, leadership of people, multi-tasking in fast-paced environments, budget preparation, Microsoft Office proficiency
Technologies
Creo Parametric
Responsibilities
Obtain market feedback to determine functional and design specifications; Create and maintain FDA complaint Design history Files (DHF); Manage project timelines and regulatory compliance; 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 plans; Assist in writing regulatory applications; Partner with operations for manufacturing setup; Participate in product introductions via sales training; Conduct post-introduction monitoring; Research industry competitors.
Seniority
Mid-to-Senior, hands-on IC with leadership responsibilities