Sr Project Engineer, Development
Core
Lead end-to-end engineering for medical device product lines from concept through FDA approval and manufacturing.
Role type
Senior Project Engineer (Mechanical Design)
Builds
Spine implants and surgical instruments
Domain
Medical Devices / 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, prototyping, design verification and validation, manufacturing setup, market research
Preferred skills
Medical device industry experience, leadership, budget preparation
Technologies
Creo
Responsibilities
Obtain market feedback to define product specifications, create and maintain Design History Files (DHF), manage project timelines and regulatory compliance, design instruments and implants, partner with vendors for prototyping, perform design verification and validation, assist in writing FDA applications, partner with operations for manufacturing setup, participate in product introductions and sales training, conduct post-introduction monitoring, research industry competitors
Seniority
Senior, hands-on IC