Principal , Microbiology & Toxicology

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The Medical Device Toxicologist will serve as a scientific leader and subject matter expert for the biological safety evaluation of medical devices, combination products, materials, and components across the product lifecycle. The role will develop risk-based biocompatibility strategies, integrate chemical and biological evidence, and translate complex toxicology data into clear product-safety conclusions and global regulatory positions. The successful candidate will pair medical device toxicology expertise with toxicology judgment, strategic problem solving, cross-functional leadership, and effective oversight of external laboratories and consultants.

This role is on-site in Fort Worth, Texas and would include:

• Lead development and execution of phase-appropriate, risk-based biological evaluation strategies for new and existing medical devices, combination products, components, materials, manufacturing changes, and product modifications.
• Author and critically review Biological Evaluation Plans and Biological Evaluation Reports that integrate device categorization, nature and duration of contact, chemical characterization, toxicological risk assessment, existing data, and biological testing.
• Apply ISO 10993 principles, including ISO 10993-1, to determine relevant biological endpoints and establish scientifically justified testing, read-across, bridging, or testing-waiver strategies.
• Integrate device extractables and leachables data, chemical and material characterizations, and exposure information with toxicological hazard data to assess patient risk and support product safety conclusions.
• Develop toxicological risk assessments for identified constituents and establish health-based exposure limits using relevant toxicology principles, weight-of-evidence methods, and computational toxicology tools.
• Serve as the medical device toxicology and biocompatibility subject-matter expert on product development, lifecycle management, remediation, and regulatory-response teams.
• Critically evaluate complex or conflicting data, identify evidence gaps and product-safety risks, and recommend pragmatic, science-based paths forward that balance patient safety, regulatory expectations, program timing, and business needs.
• Lead biocompatibility work streams and integrated project plans, including scope, milestones, dependencies, timelines, budgets, risks, and decision points.
• Contribute to global regulatory submissions and responses by authoring, reviewing, and defending medical device toxicology and biocompatibility content.

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; B.S. +3 yrs; M.S.+2 yrs; PhD +0 yrs).
• The ability to fluently read, write, understand and communicate in English.
• 5 Years of Relevant Experience.
• MS or PhD in Toxicology or a related discipline (e.g., Pharmacology, Biomedical Sciences, Pharmaceutical Sciences, Environmental Health Sciences, etc.).
• Relevant experience in pharmaceutical and/or medical device development (industry, postdoctoral, or equivalent).
• Direct experience with medical device and/or combination product development across early development, design changes, registration, and postmarket lifecycle management.
• Experience preparing regulatory submission content and…