Project Engineer
Core
Lead the design and development of endovascular medical devices from concept through commercialization, ensuring regulatory compliance and integrating clinical feedback.
Role type
Mechanical Project Engineer (Medical Devices)
Builds
Endovascular products for patients with musculoskeletal disorders
Domain
Medical Technology / Endovascular
Deliverable
production ML models | product features
Required skills
Mechanical design, CAD (CREO/SolidWorks), FDA regulatory compliance, Design History Files (DHF), Design Verification & Validation, Rapid prototyping, Market research, Cross-functional collaboration
Preferred skills
Endovascular product design experience, Medical device industry experience
Technologies
CREO, SolidWorks, Microsoft Excel, PowerPoint, Microsoft Project
Responsibilities
Lead design of endovascular products using CAD; Create and maintain FDA-compliant Design History Files; Perform design verification and validation; Obtain market feedback from surgeons to determine functional specifications; Partner with operations to set up manufacturing; Support lifecycle management of commercialized products
Seniority
Mid-level, hands-on IC