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 Title

Staff Biocompatibility Scientist

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

The Staff Biocompatibility Scientist Solutions works in St. Paul, MN in the Abbott Vascular Division.

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

As STAFF BIOCOMPATIBILITY SCIENTIST, you will make an important contribution to patient safety by supporting projects/programs in terms of biocompatibility of medical devices, materials, and processes. The person will represent the Electrophysiology Biocompatibility Group as part of Shared Services as a Subject Matter Expert (SME) in biocompatibility. This role will work closely with program/project cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements such as ISO 10993.

You will utilize your specialized knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance that affect assigned devices (Class II to Class III). You will interpret biocompatibility regulatory requirements and guidance and support biocompatibility strategy team to correctly apply regulatory requirements as appropriate to product development and change activities for assigned devices. You will also utilize your strong ability to critically review detailed scientific information and assess any gaps based on adequately supported data. The Staff Biocompatibility Scientist assesses project risks and recommends contingency plans and strategies to mitigate risks.

What You’ll Work On

• Review, approve, and 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.
• 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.
• Assess own and others’ research results in order to develop recommendations for future research directions and projects.
• Comply with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Prepares, edits, and finalizes biological evaluation safety plans and reports, synopses, regulatory documents, and related biocompatibility documents, such as testing protocols and laboratory reports.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor’s degree in one or more of the following disciplines: Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or other medical related discipline. Advanced degree (MS or PhD) preferred.
• 7+ years’ industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation. Master’s Degree or PhD in relevant engineering or scientific discipline may substitute for years of industry experience.
• Fundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological risk assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.
• Proficient with MS Office (Word, Excel, Outlook, Power Point, SharePoint, OneDrive)
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Strong technical writing skills is essential. Experience writing biological risk assessments for FDA and Notified Bodies and regulatory responses preferred.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to prioritize and meet deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.

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 $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.