Sr Biocomptibility Specialist
Core
Execute biocompatibility projects for New Product Development, Life Cycle Management, and Research, designing technical approaches for biological evaluations and analyzing test data.
Role type
Senior IC biocompatibility specialist
Builds
Biological evaluation plans, reports, and regulatory summaries for medical devices
Domain
Medical devices / Biocompatibility
Required skills
Biocompatibility assessment, toxicological risk assessment, ISO 10993 standards, extractable and leachable analysis, biomaterials knowledge, project planning, data interpretation
Preferred skills
MS or PhD in biomedical/biological fields, experience with medical device manufacturing processes
Technologies
ISO 10993 series, QMS
Responsibilities
Deliver biological evaluations of new and existing devices, execute biocompatibility studies via external labs, develop or revise biological evaluation protocols and regulatory summaries, analyze and interpret biocompatibility testing data, collaborate cross-functionally with NPD, regulatory, and project management teams
Seniority
Senior, hands-on IC