Principal Scientist, Biocompatibility

The Opportunity

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

This position works out of the following locations : St. Paul, MN, Minnetonka, MN, Burlington, MA, Westford, MA, Pleasanton, CA, Temecula, CA, Sylmar, CA, Santa Clara, CA, Sunnyvale, CA, Plymouth, MN, Irvine, CA, Portland, OR, Atlanta, GA or Plano, TX 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 toxicological assessments, chemical characterization, material characterization, processes for medical device manufacturing, and / or biocompatibility assessment.
• Experience in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
• Experience working with scientific standard organization (e.g. ISO / TC 194).
• Strong computer and general software skills
• Strong oral / written communication skills

Preferred Qualifications

• Master’s or PhD degree in biology, biochemistry, toxicology, molecular cell biology, immunology; preferably with a specialism relating to medical devices.
3 days ago