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Job description
Principal Medical Device ToxicologistWork mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.About the role: 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.Your responsibilities will include:Provide support for biocompatibility processes initiated by department managementEnsure biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirementsDemonstrate a primary commitment to patient safety and product qualityAuthor biocompatibility and chemical characterization test plans, author Biocompatibility Assessments and Reports, and assess test data and reports, as necessary, to support business objectivesAuthor toxicological risk assessments, as assigned, to support divisional objectivesAdvise 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 necessaryMaintain communications with internal customers on biocompatibility and toxicology issuesSupport problem-solving and resolution related to biocompatibility assessments, chemical characterization, and toxicological risk assessmentsConsult 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 initiativesParticipate as assigned in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirementsMay 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 toxicitiesAdvise on procedures, techniques, concepts, and approaches used at divisional levels for biocompatibility and toxicology programsRequired qualifications:PhD in Toxicology-related fieldMinimum of 10 years of professional toxicology/biocompatibility experienceProven 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 processesExperience preparing hazard assessments and risk assessmentsExperience 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 biocompatibilityMembership and leadership in professional toxicology/biocompatibility organizationsBoard-certified in toxicology (for example, DABT)Preferred qualifications:Applied knowledge and understanding of toxicology principles and best practicesWorking knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materialsWorking knowledge of regulatory standards and global regulatory requirements with respect to medical device and combination productsExperience with running GLP and nGLP studiesExcellent written and verbal communication skills
Worksite address
saint paul, MN, 55112, US
Who can apply
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