Senior Medical Device Toxicologist

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.   Advancing possibilities for a brighter tomorrow   We are seeking a Senior Medical Device Toxicologist  on a permanent basis to join our team.    Job Purpose: 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 in accordance with ISO 10993, 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.   Key Responsibilities:

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 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.

Education & Experience: Required qualifications:

Level 8 Hons Bachelor Degree (or higher) in Toxilocology or related discipline (biology, chemistry, biochemistry, biomedical engineering). Minimum of 5 years’ experience supporting medical devices. Knowledge of the biological evaluation of medical devices and / or drug-device combination products.

A MS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will