Senior Med Device Toxicologist

Purpose Statement:

Provides support for the biocompatibility and toxicology processes and related technical support to assigned business divisions in support of new product development, regulatory submissions and manufacturing and engineering changes to meet business objectives. Additionally this position is responsible for the conduct of Chemical Safety Assessments to evaluate potential extractables, leachables, and residuals and assessment of the potential for patient safety impacts related to these exposures

Job 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.

• 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 and reviewing Chemical Safety Assessments and toxicology memos as necessary to support divisional objectives.

• Responsible for consulting and advising biocompatibility specialists on the development of Biocompatibility 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 chemical risk assessments and biocompatibility assessments.

• Consults on biocompatibility, chemistry and toxicology testing 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.

• Serves as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, colorant 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.

Job Requirements:

• Candidates require to process at least Bachelor or Master in Toxicology is preferred or an alternatively chemistry, biochemistry, biology, biomedical science or a related field degree qualification.

• English; excellent written and verbal communication skills.

• Professional with an understanding and application of principle, theories, and concepts in the biocompatibility of medical devices; experience with ISO 10993 preferred. 

• Results and detail-oriented, and ability to multi-task while working against aggressive timelines.  

• Comfortable in a dynamic environment and able to work independently as well as on teams.

• Require at least 8 years medical device biocompatibility experience preferable or an equivalent combination of education and experience.

• Experience working with regulated authorities preferable.

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.