Project Engineer
Core
Managing the full lifecycle of medical device product lines from concept to post-introduction monitoring, ensuring regulatory compliance and on-time market entry.
Role type
Senior Project Engineer (Medical Devices)
Builds
Surgical instruments and implants for musculoskeletal disorders
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 software proficiency, FDA regulatory compliance, project management, manufacturing setup, market research, budget preparation
Preferred skills
Endovascular manufacturing experience, leadership of people, rapid prototyping coordination
Technologies
Creo
Responsibilities
Obtain market feedback to define functional specifications, create and maintain Design History Files (DHF), manage project timelines and regulatory compliance, design and develop instruments and implants, partner with vendors for prototyping, 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 industry competitors
Seniority
Mid-level, hands-on IC