Senior Biocompatibility Scientist II

Abbott • Temecula, CA

1d • $78,000 - $156,000 • Onsite

About The Position

The Senior Biocompatibility Scientist II works in Abbott’s Medical Device business in Temecula, California. This senior individual-contributor role supports projects and programs involving the biocompatibility of medical devices and materials, including the effects of manufacturing processes. The scientist represents Abbott’s Global Biocompatibility Group within Shared Services as a subject matter expert and works with cross-functional teams to provide biocompatibility deliverables that meet global regulatory requirements.

The role applies biocompatibility expertise throughout the product lifecycle, interprets requirements for Class II and Class III devices, and develops evaluation strategies for product development and change management. It includes reviewing scientific information, identifying gaps, assessing project risks, and recommending strategies to mitigate them. The position has no direct people-management responsibilities.

Requirements

• Bachelor’s degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or a related discipline.
• Seven or more years in progressively responsible positions in a research and development environment, or a PhD with two years of experience.
• Practical laboratory skills and knowledge of science, with the ability to apply advanced principles and techniques; expert-level ability to explain and teach experimental approaches, protocols, and scientific methods, including experimental design and data interpretation.
• Knowledge or use of regulations and standards affecting IVDs and biologics.
• Basic computer skills and ability to learn new computer programs.
• Proficiency with Microsoft Office, including Word, Excel, Outlook, PowerPoint, SharePoint, and OneDrive.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Ability to work both independently and as part of a team in a fast-paced, changing environment.
• Ability to prioritize work, complete deliverables on time, and meet deadlines.
• Strong organizational and follow-up skills, with attention to detail.
• Ability to work in a highly matrixed and geographically diverse business environment.

Nice To Haves

• Advanced degree (MS or PhD).
• Five or more years of industrial experience in medical device, pharmaceutical, or biotechnology fields, with expertise in 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 assessment methodology.
• Technical writing experience, particularly writing biological risk assessments for the FDA and Notified Bodies.
• Experience working in a broader enterprise or cross-division business-unit model.

Responsibilities

• Conduct and document biocompatibility assessments, develop evaluation plans, and prepare reports under applicable biological evaluation standards and FDA/ISO guidance using a risk-based framework.
• Evaluate design, manufacturing, and site changes, including process equivalency, material equivalence, and regulatory impact.
• Collaborate with cross-functional teams on multiple biocompatibility projects and complete deliverables on schedule.
• Analyze biocompatibility test results for adequacy in evaluating biological effects and troubleshoot unexpected results.
• Assist with 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.
• Monitor applicable standards and industry requirements, including updates and revisions to the ISO 10993 series, ISO 14971, FDA guidance, and other relevant regulations.
• Perform or assist with gap assessments when standards, regulations, or guidance change; identify deficiencies and recommend actions to maintain compliance and minimize business impact.
• Collaborate with analytical chemistry, toxicology, and preclinical safety colleagues on biological evaluation strategies.
• Comply with Abbott policies, procedures, and quality system requirements, as well as global biocompatibility regulations.
• Prepare, edit, and finalize biological evaluation safety plans, test protocols, laboratory reports, evaluation reports, synopses, regulatory submission content, and related documents.
• Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors.

Benefits

• Potential eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution and a generous 401(k) company match.
• Tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit.
• Training and career development, including onboarding programs and tuition assistance.
• Competitive compensation and incentives.
• Medical, dental, and vision coverage; wellness and occupational health programs.
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior