Project Engineer
Core
Lead design and development of surgical instruments and implants for trauma patients, driving projects from concept through commercialization while ensuring FDA compliance.
Role type
Senior IC mechanical design engineer (medical devices)
Builds
Surgical instruments and implants for trauma care
Domain
Medical technology / Orthopedics
Deliverable
production ML models | product features
Required skills
Mechanical design, CAD (CREO/SolidWorks), FDA regulatory compliance, Design History File (DHF) creation, Design verification and validation, Rapid prototyping, Market feedback integration, Cross-functional collaboration
Preferred skills
Medical device experience, Operating room exposure, Competitor research
Technologies
CREO, SolidWorks, Microsoft Excel, PowerPoint, Microsoft Project
Responsibilities
Lead design and development of surgical instruments and implants; Create and maintain FDA-compliant Design History Files; Perform design verification and validation activities; Obtain market feedback from surgeons to determine functional specifications; Partner with operations to set up manufacturing and purchasing; Support lifecycle management of commercialized products by addressing quality issues and cost improvements.
Seniority
Mid-level, hands-on IC