Project Engineer
Core
Developing biomaterials for orthopedic and therapeutic applications, including stem cell-based therapies and synthetic scaffolds, from concept through FDA approval and post-introduction monitoring.
Role type
Senior IC project engineer (biologics/biomaterials)
Builds
Biologic products for musculoskeletal disorders
Domain
Medical devices / Biologics / Orthopedics
Deliverable
production ML models | product features
Required skills
Design verification and validation, regulatory compliance (FDA), project planning, DHF management, in vivo animal study protocols, market research, sales training support
Preferred skills
MA or PhD in scientific field
Technologies
Design History Files (DHF), regulatory submission frameworks
Responsibilities
Develop biomaterials for orthopedic applications; Develop methodology and protocols for in vivo animal studies; Perform design verification and validation activities; Obtain market feedback from surgeons to determine product specifications; Create and maintain project plans and Design History Files; Manage all aspects of project to ensure timely completion and regulatory compliance; Assist with product introductions through sales training and customer visits; Maintain post introduction monitoring to address customer requests; Research market and competition to ensure cutting-edge technology
Seniority
Mid-level, hands-on IC