Principal Scientist

Principal Toxicologist, Toxicology & Biocompatibility, R&D – MedTech (Flex/Hybrid; 3 days/week on-site; no remote). Based within commutable distance of Raritan, NJ (strongly desired) or Cincinnati, OH.

You Will Be Responsible For:

• Evaluate medical device products/materials for biological safety per global regulations/standards, GLP (US FDA), and internal procedures.
• Design/initiate/coordinate/interpret biocompatibility and toxicology laboratory investigations.
• Apply technical expertise to resolve ISO 10993 biocompatibility issues and regulatory requirements.
• Coordinate biocompatibility test strategies, review documentation, and ensure deliverables completion.
• Review/interpret/summarize testing data; support risk assessment documentation.
• Provide technical guidance to internal/external partners across the product lifecycle.
• Support regulatory/notified body requests; directly interact with notified bodies (e.g., TUV, BSI).
• Identify/evaluate risks and drive resolution; participate in continuous improvement.
• Follow health, safety, and environmental (HSE) practices; ensure compliance (and supervise subordinates’ HSE compliance if applicable).

Qualifications/Requirements:

• MS or PhD in Toxicology (or related); required.
• 6+ years relevant medical device industry.
• 8–10 years in toxicology/biocompatibility assessments (medical device/pharma/consumer); medical device experience strongly preferred.
• Regulated environment experience supporting submissions/audits; worldwide registration support preferred.
• Experience with absorbable biomaterials for implantable devices (degradation/toxicokinetics); required.
• Knowledge of ISO 10993 biocompatibility/toxicology assessment and relevant standards; required.
• Familiarity with ISO 13485, ISO 10993, ISO 14971, and design control.
• Strongly preferred: lab animal care & use; manufacturing process understanding.

Required/Preferred Skills:

• Team collaboration, conflict resolution, technical leadership/mentorship.
• Strong written/verbal communication; proactive problem-solving.
• Travel up to 10%.

Benefits (time off):

• Vacation (120h/yr)
• Sick time (40h/yr; CO/Washington adjustments)
• Holiday pay (13 days/yr)
• Personal/Family time (up to 40h/yr)
• Parental leave (480h)
• Bereavement (240h immediate/40h extended)
• Caregiver leave (80h)
• Volunteer leave (32h)
• Military spouse time-off (80h)