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 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.
Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$125,300.00 – $250,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Research and Discovery
DIVISION:
AVD Vascular
LOCATION:
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza
ADDITIONAL LOCATIONS:
United States > Massachusetts > Westford : 4 Robbins Road, United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road, United States > Minnesota > Minnetonka : 14901 DeVeau Place, United States > Minnesota > Minnetonka : 14904 DeVeau Place, United States > Minnesota > Minnetonka : 3700 Williston Road, United States > Pleasanton : 5000 Franklin Dr, United States > Pleasanton : 6035 Stoneridge Dr, United States > Pleasanton : 6101 Stoneridge Dr, United States > Santa Clara : 4551 Great America Parkway, United States > Santa Clara : Building A - SC, United States > Santa Clara : Building B - SC, United States > Sunnyvale : 1310 Moffett Park Drive (Do Not Use), United States > Sunnyvale : 645 Almanor Ave, United States > Sylmar : 13150 Telfair Avenue, United States > Temecula : Building D - TD
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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