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Job Details


Abbott

Sr. Scientist, Biocompatibility (31027760)

Pharmaceuticals

All

Yearly

Full Time

No

St. Paul, Minnesota, United States

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 113,000 colleagues serve people in more than 160 countries.

Sr. Biocompatibility Scientist

Location: St Paul, MN, Pleasanton, CA or Remote USA

As Sr. 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 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 I 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 Principal Scientist assesses project risks and recommends contingency plans and strategies to mitigate risks.

Responsibilities

  • 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.

  • Assesses own and others’ research results in order to develop recommendations for future research directions and projects.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

  • Bachelor’s Degree in degree in biology, biochemistry, toxicology, molecular cell biology, immunology or relevant engineering or scientific discipline.

  • 6+ 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

  • Extensive experience in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993

  • Extensive experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).

  • Experience working in Design Control environment

Preferred

  • Master’s Degree or PhD in relevant engineering or scientific discipline.

  • 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 working in a broader enterprise/cross-division business unit model preferred.

  • Demonstrated track record of innovative scientific accomplishments, approved patents and breakthrough technical contributions. Outstanding technical leadership skills.

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

  • Ability to leverage and/or engage others to accomplish projects.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Multitasks, prioritizes and meets deadlines in timely manner.

  • Strong organizational and follow-up skills, as well as attention to detail.

  • Prior laboratory CRO experience

  • Solid working knowledge of FDA Quality System Regulations and ISO 13485

  • Proficient in MS Excel, MS Project and Power Point

  • PMP certification

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance

  • Student Loan Repayment Program

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  [Register to View] target="_blank">[Register to View]

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at [Register to View] target="_blank">[Register to View] , on Facebook at [Register to View] target="_blank">[Register to View] and on Twitter @AbbottNews and @AbbottGlobal.