PROJECT ENGINEER
Core
Lead the design and development of surgical instruments and implants using CAD software, managing projects to FDA compliance and ensuring timely completion.
Role type
Mechanical design project engineer (medical devices)
Builds
Surgical instruments and implants
Domain
Medical devices / Orthopedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design, CAD (CREO/SolidWorks), FDA regulatory compliance, project planning, design verification and validation, 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; Create and maintain FDA-compliant Design History Files; Perform design verification and validation activities; 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
Mid-level, hands-on IC