Biocompatibility Manager Jobs (NOW HIRING)

Senior Biocompatibility Scientist II

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.

• 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of either or Santa Clara, CA, Temecula, CA or St Paul, MN location for our Medical Device business. For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whetherit'sglucose 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 than10,000 peoplehave healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than500,000 peoplewith diabetes from routinengersticks.

What You'll Work On

As aSenior Biocompatibility Scientist II, 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 information,identifygaps, 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 biocompatibility,comply 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.

Required Qualifications

Bachelor's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or related discipline.

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.

Preferred Qualifications

Advanced degree (MS or PhD) preferred.

5+ years of industrial experience in Medical Device, Pharmaceutical, or Biotechnology fields withexpertisein biocompatibility, toxicology, and/or special process validation.

A master's 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.

What We Offer

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

• A fast-paced work environment where your safety is our priority

• Production areas that are clean, well-lit and temperature-controlled

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

• 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

Apply Now

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.

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