PROJECT ENGINEER
Core
Managing the full lifecycle of medical device product lines from concept through design, prototyping, testing, manufacturing, and FDA approval.
Role type
Senior mechanical design project engineer (medical devices)
Builds
Surgical instruments and implants for patients with musculoskeletal disorders
Domain
Medical device engineering / Orthopedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mechanical design engineering, Creo software, FDA regulatory compliance, project management, design verification and validation, manufacturing setup, market feedback analysis
Preferred skills
medical device experience, budget management, report writing
Technologies
Creo, Microsoft Office
Responsibilities
Obtain market feedback from surgeons to determine functional specifications; Create and maintain Design History Files (DHF); Manage assigned projects for timely completion and regulatory compliance; Design and develop instruments and implants; Partner with prototype shops and vendors for rapid prototyping; Perform design verification and validation activities; Collaborate with marketing to develop forecasts; Assist in writing regulatory applications to the FDA; Partner with operations to setup manufacturing; Participate in product introductions via sales training and customer visits; Maintain post-introduction monitoring.
Seniority
Mid-level, hands-on IC