Senior Project Engineer, Biomaterials
Core
Lead engineering functions for biomaterials product lines from concept through FDA approval and manufacturing, serving patients with musculoskeletal disorders and surgeons.
Role type
Senior Project Engineer (Biomaterials)
Builds
Instruments and implants in biomaterials, tissue engineering, and drug delivery
Domain
Medical device / Biomedical engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biomaterials development (hydrogels, scaffolds, coatings, porous materials), in vivo testing, project management, regulatory compliance (FDA), design verification and validation, market research, manufacturing setup
Preferred skills
leadership, multi-tasking, budget preparation, report writing
Technologies
Microsoft Office
Responsibilities
Obtain market feedback to determine functional and design specifications; Create and maintain project plans and FDA complaint Design history Files; Manage all aspects of project to ensure timely completion and regulatory compliance; Design and develop instruments and implants; Design experiments, analyze data, troubleshoot protocols, and document results; Perform design verification and validation activities; Partner with marketing to develop forecasts and market plans; Assist in writing regulatory applications to the FDA; Collaborate with operations to setup manufacturing; Participate in product introductions through sales training and customer visits; Maintain post introduction monitoring; Research market and competition; Ensure compliance with governmental laws and regulations
Seniority
Senior, hands-on IC