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Medical Device Toxicologist II Job

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Date: Jan 11, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations: US-IN-Spencer; US-MA-Marlborough; US-MN-Arden Hills; Remote optional 

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About This Role:

The Scientist II – 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. 

 

Your Responsibilities 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.

 

 

What We’re Looking For:

Minimum Qualifications

  • A BS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering), with 6+ years of related experience
  • A MS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering), with 3+ years of related experience
  • A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering), with 1+ years of related experience
  • Knowledge of the biological evaluation of medical devices and / or drug-device 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

 

Preferred Qualifications

  • 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.

 

About us

As a global medical technology leader for more than 35 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.

 

Requisition ID: 473390

 


Nearest Major Market: Minneapolis

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