Senior Medical Device Toxicologist

Work mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-MN-Arden Hills; US-MN-Maple Grove. 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 Senior Medical Device 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 extractables and leachables 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. This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist Your responsibilities will include: Provide support for biocompatibility processes initiated by department management and 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. Responsible for authoring biocompatibility and chemical characterization test plans, author Biocompatibility Assessments and Reports, and assess test data and reports as necessary to support business objectives. Responsible for authoring toxicological risk assessments as assigned to support divisional objectives. Responsible for advising more junior staff on the development of Biocompatibility and chemical characterization test plans, reviewing and approving Biocompatibility Assessments and Reports, and assessing test data and reports as necessary to support business objectives, including authoring such reports as necessary. Maintains communications with internal customers on biocompatibility and toxicology issues, support problem solving and resolution related to related to biocompatibility assessments, chemical characterization, and toxicological risk assessments Consults 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). Provides consultation on regulatory requirements related to medical device submissions for assigned divisions and in support of corporate initiatives. Participates 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. Advises on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs. Required qualifications: Minimum Bachelor's degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering) Minimum 5 years of related experience. Knowledge of the biological evaluation of medical devices and/or drug-device combination products. Preferred qualifications: Master's degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Preferred Masters and 3 years of related experience PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Preferred PhD and 1 years of related experience 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 Prior experience with running GLP and non GLP studies