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Senior Medical Device Toxicologist Job

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Date: Sep 23, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-IN-Spencer; US-MN-Arden Hills; US-MN-Minnetonka


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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 This Role:
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 for 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. 
Prefered that individual can be based out of any of the following sites: Spencer, IN; Marlborough, MA; Arden Hills, MN; Minnetonka, MN but willing to look at remote for the right individual


Your responsibilties will include:

  • Working closely with R&D, regulatory affairs, quality engineering, and manufacturing, maintain close communications with internal customers on the strategies for the biological evaluation of medical devices, including chemical characterization, biocompatibility testing, and toxicological risk assessment.
  • Develop testing strategies, coordinate and monitor testing with external research labs, assess data, and author biological evaluation reports for assigned business divisions.
  • Conduct toxicological risk assessments in conformance with established guidance (ISO 10993, ICH, etc.).
  • Providing guidance and interpretation of regulatory requirements related to medical device submissions for assigned business divisions
  • At the basis of every decision, demonstrates a primary commitment to patient safety and product quality.


Required Qualifications

  • Bachelors degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering)
  • 6+ years of related professional experience
  • Knowledge of the biological evaluation of medical devices and / or drug-device combination products

Preferred Qualifications

  • Advanced degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering)
  • Strong knowledge and understanding of toxicology principles and best practices
  • Applied knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials.
  • Applied knowledge of regulatory standards and global regulatory requirements with respect to medical device and combination products.
  • 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



Requisition ID: 500476


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 (NYSE: BSX) 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!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


Nearest Major Market: Boston

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