Principal Medical Device Toxicologist
About The Position
The Principal Toxicologist at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. Additionally, this position is responsible for the biological evaluation of medical device products, including the conduct of toxicological risk assessments based on data derived from extractable and leachable studies, in support of new product development and sustaining activities, as well as in support of global regulatory submissions. Global Toxicology and Biocompatibility plays a critical role in medical device development, ensuring patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three (3) days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Requirements
- PhD in Toxicology-related field
- Minimum of 10 years of professional toxicology/biocompatibility experience
- Proven expertise in the biological evaluation of medical devices and / or drug-device combination products (ISO 10993)
- Experience using computational models for the purposes of carcinogenic risk assessment (Benchmark Dose Modeling)
- Experience establishing formal toxicology processes
- Experience preparing hazard assessments and risk assessments
- Experience communicating toxicology and biocompatibility concepts to members at all levels of an organization, and to members of varying levels of technical knowledge in toxicology and biocompatibility
- Membership and leadership in professional toxicology/biocompatibility organizations
- Board-certified in toxicology (for example, DABT)
Nice To Haves
- Applied knowledge and understanding of toxicology principles and best practices
- Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials
- Working knowledge of regulatory standards and global regulatory requirements with respect to medical device and combination products
- Experience with running GLP and nGLP studies
- Excellent written and verbal communication skills
Responsibilities
- Provide support for biocompatibility processes initiated by department management
- Ensure biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements
- Demonstrate a primary commitment to patient safety and product quality
- Author biocompatibility and chemical characterization test plans, author Biocompatibility Assessments and Reports, and assess test data and reports, as necessary, to support business objectives
- Author toxicological risk assessments, as assigned, to support divisional objectives
- Advise earlier-career staff on the development of biocompatibility and chemical characterization test plans, review and approve Biocompatibility Assessments and Reports, and assess test data and reports, as necessary, to support business objectives, including authoring such reports as necessary
- Maintain communications with internal customers on biocompatibility and toxicology issues
- Support problem-solving and resolution related to biocompatibility assessments, chemical characterization, and toxicological risk assessments
- Consult on biocompatibility, chemistry, and toxicology testing and strategies related to new investigational and strategic device development programs during Technology and Product Development Programs (TDP/PDP)
- Provide consultation on regulatory requirements related to medical device submissions for assigned divisions and in support of corporate initiatives
- Participate as assigned in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements
- May serve as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, color additives, exposure assessments of chemicals, and other chemical toxicities
- Advise on procedures, techniques, concepts, and approaches used at divisional levels for biocompatibility and toxicology programs
Benefits
- Relocation assistance is not available for this position at this time.
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
