PROJECT ENGINEER
Core
Lead engineering functions for medical device product lines from concept through FDA approval and manufacturing, ensuring high-quality, on-time product introductions for patients with musculoskeletal disorders.
Role type
Senior mechanical design project engineer (medical devices)
Builds
Surgical instruments and implants for orthopedic procedures
Domain
Medical technology / Orthopedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design engineering, Creo, SolidWorks, FDA regulatory compliance, project management, design verification and validation, market research, manufacturing setup
Preferred skills
Medical device experience, budget management, report writing
Technologies
Creo, SolidWorks, Microsoft Office
Responsibilities
Obtain market feedback to determine functional specifications, create and maintain Design History Files (DHF), manage project timelines and regulatory compliance, design and develop instruments and implants, partner with prototype shops for rapid prototyping, perform design verification and validation, assist in writing regulatory applications to the FDA, partner with operations for manufacturing setup, participate in product introductions via sales training, maintain post-introduction monitoring, research industry competitors
Seniority
Mid-level, hands-on IC