Project Engineer
Core
Design and develop instruments and implants for musculoskeletal disorders, managing projects from concept to manufacturing while ensuring regulatory compliance.
Role type
Mechanical design engineer (medical devices)
Builds
Instruments and implants for orthopedic surgery
Domain
Medical technology / Orthopedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design, Creo, SolidWorks, FDA Design History File (DHF) creation, project management, regulatory compliance, market research, manufacturing setup
Preferred skills
Medical device experience, budget management, sales training support
Technologies
Creo, SolidWorks, Microsoft Office
Responsibilities
Obtain market feedback to determine functional specifications, create and maintain FDA Design History Files, 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, partner with operations for manufacturing setup, participate in product introductions and sales training, monitor post-introduction customer requests, research industry competitors
Seniority
Mid-level IC