Principal Scientist/Engineer, Biomaterials & Toxicological Sciences

Therakos•Nashville, TN

About The Position

The Principal Scientist/Engineer, Biomaterials & Toxicological Sciences provides technical leadership in evaluating, selecting, and characterizing materials and assessing biological safety for current and next-generation medical device, combination product, and cell therapy platforms. The role serves as the organization’s subject matter expert in biomaterials, biocompatibility, extractables and leachables, toxicological risk assessment, hemocompatibility, and biological evaluation strategy. Working across Research, Engineering, Clinical, Regulatory, Quality, and Operations, this individual helps ensure that materials and processes support safe, effective, and compliant products throughout the product lifecycle. The successful candidate applies scientific expertise and engineering judgment to guide material innovation, support regulatory submissions, reduce development risks, and influence long-term platform strategy.

Requirements

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.
Ability to develop scientific rationales supporting design inputs, risk management activities, design controls, and regulatory submissions.
Strong technical leadership skills, including the ability to guide cross-functional teams, external laboratories, suppliers, consultants, and regulatory interactions.
Demonstrated ability to interpret biological test results, assess material and process changes, and recommend appropriate risk mitigation strategies.
Outstanding written, verbal, scientific, and technical communication skills, including the ability to advise senior leadership on complex technical matters.
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.
PhD in Toxicology, Biomaterials Science, Biomedical Engineering, Materials Science, Chemical Engineering, Polymer Science, or a related discipline required; the posting also labels this qualification as preferred.

Nice To Haves

Experience with extracorporeal therapies, blood-processing devices, cell therapy, or immunotherapy platforms.
Experience with FDA submissions, EU MDR Technical Files, and global market registrations.
Experience working with external CROs and biocompatibility laboratories.
American Board of Toxicology certification.

Responsibilities

Serve as the technical lead for biomaterial selection and evaluation across device, disposable, and combination-product systems.
Assess polymers, elastomers, coatings, adhesives, resins, and blood-contacting materials used in therapeutic systems.
Identify emerging materials and surface technologies that may improve product performance, biocompatibility, manufacturability, and clinical outcomes.
Partner with product development teams to incorporate biological safety requirements early in the design process.
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 recommend risk mitigation strategies for product 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.
Collaborate with systems, mechanical, electrical, manufacturing, and quality engineers to ensure material decisions support product requirements.
Provide technical leadership for verification and validation activities related to biomaterials and biological safety.
Lead root-cause investigations involving material failures, biocompatibility concerns, contamination events, and product performance issues.
Evaluate supplier materials, manufacturing processes, sterilization methods, packaging systems, and shelf-life impacts on biological safety.
Serve as the primary scientific interface with external test laboratories, toxicologists, material suppliers, consultants, and regulatory authorities.
Maintain awareness of evolving scientific literature, standards, and regulatory expectations affecting biomaterials and toxicology.
Mentor scientists and engineers in biomaterials science, toxicology, risk assessment, and biological evaluation methodologies.
Advise leadership on product safety, regulatory risk, material-related opportunities, and future technology investments.