Senior Biocompatibility Specialist
Core
Plan, execute, evaluate, and document biocompatibility studies and justifications to support product safety and performance tests for medical devices.
Role type
Senior Biocompatibility Specialist
Builds
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Domain
Medical device industry + biocompatibility testing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biological testing, biocompatibility, research and development, ISO standards compliance, biological evaluation of medical devices per ISO 10993, contamination controls, risk management, design verification and validation, project planning, critical path management, budget management, nonconforming material review, process change control, supplier interface, manufacturing process improvement, sterilization techniques (gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, dry heat)
Preferred skills
Medical device product development lifecycle, cross-functional team leadership, complex initiative leadership from concept through release
Technologies
ISO 10993, ISO 13485, ISO 14971, 21CFR820, AAMI, USP, ANSI, EPA, EU guidelines
Responsibilities
Plan and execute biocompatibility studies and test campaigns; define evaluation strategies for medical devices; analyze materials and design challenges for biological safety; develop protocols, reports, and regulatory summaries; review and approve nonconforming material and process change documentation; support new product development and design verification; ensure compliance with global regulatory requirements; act as point of contact for suppliers and engineers; participate in manufacturing process improvement.
Seniority
Senior, hands-on IC
