SENIOR PROJECT ENGINEER
Core
Lead the design and development of surgical instruments and implants for patients with musculoskeletal disorders, ensuring FDA compliance and translating clinical insights into tangible solutions.
Role type
Senior IC mechanical design 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, Design History Files (DHF) creation, Design verification and validation, Rapid prototyping, Market feedback integration, Lifecycle management
Preferred skills
Medical device experience, Operating room exposure, Cadaver lab experience
Technologies
CREO, SolidWorks, Microsoft Excel, Microsoft PowerPoint, Microsoft Project
Responsibilities
Lead design and development of surgical instruments and implants using CAD software; 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 cross-functional teams on manufacturing setup and supply chain; Support lifecycle management of commercialized products by addressing quality issues and cost improvements.
Seniority
Senior, hands-on IC