Boston Scientific Senior Medical Device Toxicologist 

United States, Massachusetts, Marlborough 

395276534

About the role:

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

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.