Senior Biocompatibility Scientist

Abbott Laboratories; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Job summary

Abbott Laboratories in Sylmar, CA, is seeking a Senior Biocompatibility Scientist to ensure patient safety through biocompatibility evaluations of medical devices and materials. You will serve as a SME within the Global Biocompatibility Group, collaborating with cross‑functional teams to deliver compliant data for regulatory submissions.

The role requires deep knowledge of ISO 10993, FDA guidance, and lifecycle biocompatibility assessment.

Qualifications

• Bachelor’s degree in Biomedical Engineering or related field; Master’s preferred.
• 5+ years of industrial experience in Medical Device, Pharmaceutical, or Biotechnology fields.
• Fundamental understanding of ISO 10993, biomaterials, toxicology risk, and safety assessments.

Responsibilities

• Prepare biocompatibility plans and reports, regulatory documents, and lab reports.
• Analyze and interpret biocompatibility test results to assess data adequacy.
• Review and deliver assessments in compliance with FDA/ISO guidance.
• Support cross-functional teams to meet project timelines and budgets.
• Assist regulatory submissions and respond to information requests.
• Maintain knowledge of external standards and ensure device safety.

Skills

MS Office

Communication skills

Technical writing

Teamwork

Problem solving

Education

Bachelor’s degree in Biomedical Engineering or related

Master’s degree preferred

Tools

SharePoint

OneDrive

CoPilot

Job description

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 122,000 colleagues serve people in more than 160 countries.

Job Description

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 our Sylmar, CA location. As a Senior Biocompatibility Scientist, you will play a crucial role in ensuring patient safety by supporting projects and programs related to the biocompatibility of medical devices, materials, and processes. You will represent the 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, such as ISO 10993. You will leverage your specialized knowledge of medical device biocompatibility throughout the product lifecycle and your understanding of biocompatibility regulations and guidance affecting Class II to Class III devices.

Responsibilities

• Prepare, edit, and finalize biological evaluation safety plans and reports, synopses, regulatory documents, and related biocompatibility documents, such as testing protocols and laboratory reports.
• Perform and assist with gap analysis of external standards, regulatory requirements, and guidance associated with biological safety evaluation, minimizing negative impacts on Abbott medical devices and business.
• Analyze biocompatibility test results to determine data adequacy for biological effects and troubleshoot unexpected results using problem‑solving skills and technical knowledge.
• Review, approve, and deliver biocompatibility assessments, evaluation plans, and reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk‑based framework.
• Participate in the development and implementation of overall biocompatibility strategies.
• Participate in design and risk review meetings to address device biological safety concerns and ensure proper documentation of biological safety assessments and test plans/reports.
• Collaborate with cross‑functional teams to support multiple projects requiring biocompatibility evaluation, ensuring timely completion of tasks to meet project schedules.
• Assist with regulatory submissions to global agencies, elaborating on biocompatibility strategy and data in response to additional information requests.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Assess research results to develop recommendations for future research directions and projects.

Option to upgrade the position to Senior II scientist based on candidate qualifications.

Skills and Abilities Required

Proficient with MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive and CoPilot). 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. Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Strong organizational skills with attention to detail and the ability to effectively prioritize and meet deadlines. Experience in cross‑functional enterprise environments and the ability to work effectively within a highly matrixed, geographically diverse organization.

Education and Experience Required

Bachelor’s degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or other medical‑related disciplines. Master’s degree preferred. 5+ years of industrial experience in Medical Device, Pharmaceutical, or Biotechnology fields. material science. Fundamental understanding or direct experience with ISO 10993 standards, biomaterials, toxicological risk assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.

Location

JOB FAMILY: Research and Discovery DIVISION: MD Medical Devices LOCATION: United States > Sylmar : 15900 Valley View Court ADDITIONAL LOCATIONS: United States > Sylmar : 13150 Telfair Avenue

Work Details

WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Compensation

The base pay for this position is $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted.

EEO / Diversity

Abbott is an Equal Opportunity Employer, committed to employee diversity. 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.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Company Culture

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.