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
Senior IC mechanical design 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 and validation, Rapid prototyping, Market research, Lifecycle management
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; Partner with prototype shops and vendors for rapid prototyping; Assist in writing regulatory applications to the FDA; Obtain market feedback from surgeons to determine functional specifications; Support surgical cases in the operating room to gather real-time feedback; Collaborate with operations to set up manufacturing and purchasing; Drive design updates and documentation revisions for compliance and performance.
Seniority
Mid-level, hands-on IC