Who Our Client Is:

Our client develops medical device, combination product, and cell therapy platforms. Their teams span Research, Engineering, Clinical, Regulatory, Quality, and Operations. They are focused on advancing current and next-generation therapeutic systems that are safe, effective, and compliant.

What Our Client Needs:

Our client is seeking a Principal Scientist/Engineer, Biomaterials & Toxicological Sciences to work on-site in Franklin, TN. This role provides technical leadership in the evaluation, selection, characterization, and biological safety assessment of materials used across their platforms. As the organization's subject matter expert for biomaterials, biocompatibility, extractables and leachables, toxicological risk assessment, hemocompatibility, and biological evaluation strategy, you will guide material innovation, support regulatory submissions, de-risk development programs, and influence long-term platform strategy.

What You'll Do:

• Serve as the technical lead for biomaterial selection and evaluation across device, disposable, and combination-product systems, including polymers, elastomers, coatings, adhesives, resins, and blood-contacting materials.
• Lead biological evaluation strategies in accordance with ISO 10993, ISO 14971, FDA guidance, EU MDR, and global regulatory expectations.
• Perform and oversee toxicological risk assessments, including chemical characterization, extractables and leachables assessments, and margin-of-safety calculations.
• Interpret biological test results and determine risk mitigation strategies for design changes, supplier changes, manufacturing modifications, and regulatory submissions.
• Author, review, and approve biological evaluation reports, toxicological risk assessments, protocols, laboratory reports, and related technical documentation.
• Partner with product development, systems, mechanical, electrical, manufacturing, and quality engineers to build biological safety requirements into the design process early.
• Lead root-cause investigations involving material failures, biocompatibility concerns, contamination events, and product performance issues.
• Serve as the primary scientific interface with external test laboratories, toxicologists, material suppliers, consultants, and regulatory authorities.
• Mentor scientists and engineers, and act as a trusted technical advisor to leadership on product safety, regulatory risk, and future technology investments.

What You'll Need:

• PhD in Toxicology, Biomaterials Science, Biomedical Engineering, Materials Science, Chemical Engineering, Polymer Science, or a related discipline.
• Minimum 10+ years of industry experience in medical devices, combination products, biologics, cell therapy, or other regulated healthcare products.
• Demonstrated experience authoring biological evaluation reports and toxicological risk assessments.
• Experience leading cross-functional development programs from concept through commercialization.
• Deep expertise in biomaterials science, biocompatibility, toxicological risk assessment, and biological evaluation strategy.
• Strong working knowledge of ISO 10993, ISO 14971, FDA guidance, EU MDR, and global regulatory expectations.
• Expertise in extractables and leachables, chemical characterization, margin-of-safety calculations, hemocompatibility, and blood-contacting medical devices.
• Outstanding written, verbal, scientific, and technical communication skills, with the ability to advise senior leadership on complex technical matters.
• Preferred: American Board of Toxicology certification; experience with extracorporeal therapies, blood-processing devices, cell therapy, immunotherapy platforms, FDA submissions, EU MDR Technical Files, global market registrations, external CROs, and biocompatibility laboratories.

What They Offer:

• Competitive benefits package
• Opportunities for professional development and career growth
• Collaborative and innovative work environment