Senior Project Engineer
Core
Leading the full lifecycle of medical device product development from concept to market introduction, ensuring regulatory compliance and manufacturing readiness for spine surgery solutions.
Role type
Senior Project Engineer (Medical Devices)
Builds
Spine surgery instruments and implants
Domain
Medical Technology / Orthopedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design engineering, FDA regulatory compliance, Pro/E software, project management, design verification and validation, market research, manufacturing setup, budget preparation
Preferred skills
Medical device industry experience, leadership of engineering teams, rapid prototyping coordination
Technologies
Pro/E
Responsibilities
Obtain market feedback from surgeons to define product specifications; Create and maintain FDA-compliant Design History Files; Manage project timelines and regulatory compliance; Design and develop instruments and implants; Partner with vendors for prototyping; Perform design verification and validation; Collaborate on market forecasts and regulatory applications; Setup manufacturing and purchasing processes; Conduct sales training and customer visits; Monitor post-introduction product performance.
Seniority
Senior, hands-on IC with leadership responsibilities