Senior 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.Youllalso have access to:

Career development with an international company where you can grow the career you dream of

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with high employer contribution

Tuition reimbursement theFreedom 2 Savestudent debtprogramandFreeUeducation benefit - an affordable and convenient path to getting a bachelors degree

A company recognized asa great placeto 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

For years Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whetheritsglucose monitoring system innovative therapies for treating heart disease or products that help people with chronic pain or movement disorders our medical device technologies are designed to help people live their lives better and healthier. Every day our technologies help more than10000 peoplehave healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than500000 peoplewith diabetes from routinefingersticks.

• Supervisory Organization:Global Biocompatibility & Research Chemistry

• Business Title:Senior Biocompatibility Scientist I

• Employee Type: Regular

• Management Level: 5

• Time Type: Full time

• FTE: 100.00%

Senior Biocompatibility ScientistI

As aSenior Biocompatibility Scientist you will play a crucial role in ensuring patient safety by supporting projects and programs related to the biocompatibility of medical devices and materials including the impact of manufacturing processes. You willrepresentthe Global Biocompatibility Group within Shared Services as a Subject Matter Expert (SME) in biocompatibility. This role involves close collaboration with cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements including but not limited to the ISO 10993 series of standards ISO 14971 FDA Biocompatibility Guidance and Regulation (EU) 2017/745.

You willleverageyour specialized knowledge of medical device biocompatibility throughout the product lifecycle and interpret regulatory requirements and guidance governing Class II and Class III devices. You will apply biocompatibility requirements and develop evaluation strategies across product development and change management activities. Additionally you will critically review detailed scientific informationidentifygaps and assess project risks recommending contingency plans and strategies to mitigate these risks.

This role is a senior individual contributor position and does not include direct people management responsibilities.

Responsibilities:

• Conduct and document biocompatibility assessments develop evaluation plans and prepare reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.

• Evaluate design manufacturing and site changes including evaluation of process equivalency and material equivalence as well as regulatory impact

• Collaborate with cross-functional teams to support multiple projects requiring biocompatibility evaluation ensuringtimelycompletion of tasks to meet project schedules.

• Analyze biocompatibility test results todeterminedata adequacy for biological effects; troubleshoot unexpected results using problem-solving skills and technical knowledge.

• Assistwith regulatory submissions and prepare responses to questions nonconformances and deficiencies from global authorities.

• Participate in design and risk review meetings to address device biological safety concerns.

• Maintain comprehensive knowledge of all applicable standards and industry requirements for biological safety including monitoring updates ongoing revisions and upcoming changes to the ISO 10993 series ISO 14971 FDA guidance and other relevant regulations.

• Perform andassistwith gap assessments when standards regulations or guidance are updated toidentifypotential deficiencies inpreviousevaluationsrelativeto new requirements; recommend actions to ensure continued compliance and minimize business impact.

• Participate in the development and implementation of overall biological evaluation strategies in collaboration with colleagues in analytical chemistry toxicology and preclinical safety as applicable.

• In addition to global regulations pertinent to biocompatibilitycomply withAbbott policies procedures and quality system requirements.

• Prepare edit andfinalizebiological evaluation safety plans test protocols lab reports evaluation reports synopses regulatory submission content and related biocompatibility documents.

• Maintain positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.

Skills and Abilities Required:

• Proficient with MS Office (Word Excel Outlook PowerPoint SharePoint OneDrive).

• Strong verbal and written communication skills with the ability to effectively communicate at multiple levels within the organization.

• Strong technical writing skills with experience in writing biological risk assessments for FDA and Notified Bodies preferred.

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

• Ability to prioritize complete deliverablesin a timely manner and meet deadlines.

• Strong organizational and follow-up skills with 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.

Required Qualifications:

• Associates Degree( 13 years)

• Minimum 4 years

PreferredQualifications:

• Bachelors degree in Biomedical Engineering Molecular/Cell Biology Biochemistry Materials Science Chemistry Toxicology or related discipline. Advanced degree (MS or PhD) preferred.

• 3 years of industrial experience in Medical Device Pharmaceutical or Biotechnology fields withexpertisein biocompatibility toxicology and/or special process validation. A masters degree or PhD in a relevant engineering or scientific discipline may substitute for years of industry experience.

• Fundamental understanding or direct experience with ISO 10993 standards biomaterials toxicological risk assessment extractable and leachable analysis medical device manufacturing processes and biocompatibility assessmentmethodology.

• Role level may be adjusted to Senior Biocompatibility Scientist II based on candidate qualifications.

What We Offer

At Abbott you can havea good jobthat can grow intoa great career. We offer:

• A fast-paced work environmentwhere your safety is our priority

• Production areas that arecleanwell-litand temperature-controlled

• Training and career development with onboarding programs for new employees and tuitionassistance

• Financial securitythrough competitive compensationincentivesand retirement plans

• Health care and well-being programsincluding medical dental visionwellnessand occupational health programs

• Paid time off

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

• The stability of a companywith 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:

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.

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