Senior Biocompatibility Scientist II

What you'll do

• Conduct and document biocompatibility assessments and evaluation plans in compliance with ISO 10993 and FDA standards.
• Evaluate the regulatory impact of design, manufacturing, and site changes regarding material and process equivalency.
• Analyze test results to determine data adequacy for biological effects and troubleshoot unexpected results.
• Prepare technical documentation including safety plans, test protocols, lab reports, and content for regulatory submissions.
• Perform gap assessments when standards or regulations are updated to ensure continued compliance of previous evaluations.
• Serve as a Subject Matter Expert to provide biocompatibility guidance across the product lifecycle.
• Participate in design and risk review meetings to address specific device biological safety concerns.

What we're looking for

• Bachelor's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or a related discipline.
• 7 years of experience in a research development environment or a PhD with 2 years of experience.
• Expert level knowledge of experimental approaches, protocols, and scientific methods for designing experiments and interpreting data.
• Knowledge and use of regulations and standards affecting IVDs and Biologics.
• Proficiency in MS Office suite including Word, Excel, Outlook, PowerPoint, SharePoint, and OneDrive.
• Strong technical writing skills with experience writing biological risk assessments for FDA and Notified Bodies preferred.
• Experience in Medical Device, Pharmaceutical, or Biotechnology fields with expertise in biocompatibility and toxicology preferred.
• Fundamental understanding of ISO 10993 standards, biomaterials, toxicological risk assessment, and extractable/leachable analysis.