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.

Preferred qualifications:

• A MS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with a MS and 3+ years of related experience.
• A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with a 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.
• Experience with running GLP and nGLP studies
• Excellent written and verbal communication skills.
• Results and detail-oriented
• Able to multi-task while working against aggressive timelines.
• Comfortable in a dynamic environment and able to work independently as well as on teams.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email [email protected].

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