[Hiring] Senior Medical Device Toxicologist @Geosyntec Consultants, Inc.

Role Description

Gradient, a Geosyntec Company, is seeking a Senior Medical Device Toxicologist to assist colleagues and clients in toxicological risk assessments and biological safety evaluations for medical devices. You will have the opportunity to work fully remote from your home-office in Tustin, California and join our growing practice supporting our Seattle, WA operations.

• Possess in depth understanding of Biological Safety regulations (ISO 10993 and ISO 18562) and geography-specific requirements for both the USA and European Union to support regulatory submissions.
• Review and analyze technical data from multiple sources to assess potential toxicological risks and compliance to current regulations.
• Conduct strategic biological safety evaluation programs for medical devices that include:
  • Hazard identification
  • Literature reviews
  • Use of new and existing biological safety data
  • Design of chemical characterization studies for extractables and leachables
  • Toxicological risk assessments
• Coordinate with external labs to communicate test methods, sample submission, and review of test lab reports.
• Manage projects related to biomedical toxicological risk assessment and/or biocompatibility related projects.

Qualifications

• Bachelor’s degree in toxicology or related field (required)
• Advanced degree in toxicology or related field (strongly preferred)

Requirements

• At least 8 years (10+ preferred) in the field of medical device or pharmaceutical biocompatibility; or equivalent combination of education and experience (required)
• Exceptional written and oral communication (required)
• Excellent quantitative skills (required)
• The ability to work independently in a challenging and fast-paced work environment (required)
• Prior consulting or industry experience in medical device or pharmaceutical field, including managing projects with multiple staff (preferred)
• Strong data management experience (preferred)
• Experienced in medical device material selection and manufacturing processes to evaluate patient/product safety (preferred)

Benefits

• 9 paid holidays
• 2 floating holidays
• A minimum of 8 sick days
• A minimum of 11 vacation days per year
• Medical, dental, vision, life, and disability insurance
• 401(k)
• A variety of leaves of absences and other benefits to eligible employees