Sr Project Engineer
Core
Lead the design and development of surgical instruments and implants, managing projects from concept to FDA compliance while gathering clinical feedback from surgeons.
Role type
Senior IC mechanical design engineer (medical devices)
Builds
Surgical instruments and implants for patients with musculoskeletal disorders
Domain
Medical devices / Orthopedics
Deliverable
production ML models | product features
Required skills
Mechanical design, CAD (CREO/SolidWorks), FDA regulatory compliance, project management, cross-functional collaboration, market research, lifecycle management
Preferred skills
Medical device experience, operating room exposure, cadaver lab experience
Technologies
CREO, SolidWorks, Microsoft Excel, PowerPoint, Microsoft Project
Responsibilities
Lead design and development of surgical instruments and implants using CAD; Create and maintain FDA-compliant Design History Files; Obtain market feedback from surgeons to determine functional specifications; Collaborate with operations to set up manufacturing and purchasing; Support lifecycle management of commercialized products by addressing quality issues and cost improvements
Seniority
Senior, hands-on IC