Principal Scientist, Biocompatibility

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Job Title

Principal Scientist, Biocompatibility

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.  

This position works out of our St. Paul, MN location in the Abbott Vascular Division.  

Senior-level contributor responsible for serving as a lead SME in biocompatibility and focuses on the toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety of Abbott medical devices in accordance with applicable global regulatory guidelines.

What You’ll Work On

• Deliver biocompatibility assessments and biocompatibility evaluation plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.
• Collaborate with a cross-functional team to support multiple projects requiring biocompatibility evaluation ensuring timely completion of required tasks to meet project schedules.
• Interacts directly with functional groups including R&D groups, Preclinical, Regulatory, Analytical Chemistry, and Quality groups in the Abbott various business Divisions and CROs.
• Analyze biocompatibility test results to determine adequacy of data to meet requirements for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
• Assist with regulatory submissions to global regulatory agencies in order to elaborate on the biocompatibility strategy and data in response to additional information requests.
• Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports.
• Maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices.
• Perform and assist gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on Abbott medical devices and business.
• Participate in development and implementation of overall biocompatibility strategies

Required Qualifications

• Bachelor’s degree in biology, biochemistry, toxicology, molecular cell biology, immunology;
• Minimum 15 years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations with a focus in medical devices
• Good understanding of and experience of applying the principles, theories, and concepts in biocompatibility per ISO 10993
• Experience with biomaterials, toxicological assessments, E & L analysis for materials, container-closure systems, processes for medical device manufacturing, and biocompatibility assessment is a strong plus.
• Experience in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 109