Sr Project Engineer, Development
Core
Senior Project Engineer leading the full lifecycle of medical device product development from concept to FDA approval and manufacturing.
Role type
Senior IC mechanical design engineer (medical devices)
Builds
Spine implants and surgical instruments
Domain
Medical device / Orthopedics
Required skills
Mechanical design engineering, Creo software, FDA regulatory compliance, project management, prototyping, design verification and validation, market research
Preferred skills
Leadership, multi-tasking, budget preparation, Microsoft Office
Responsibilities
Obtain market feedback to define product specifications, create and maintain Design History Files (DHF), manage projects for timely completion and quality, design instruments and implants using Creo, partner with prototype shops and vendors, perform design verification and validation, assist in writing regulatory applications, partner with operations for manufacturing setup, participate in product introductions and sales training, conduct post-introduction monitoring, research competitors
Seniority
Senior, hands-on IC