Senior Biocompatibility Scientist II

Abbott • Temecula, CA

4d • 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 the Global Biocompatibility Group within Shared Services as a subject matter expert and collaborates with cross-functional teams to deliver biocompatibility work in compliance with global requirements, including the ISO 10993 series, ISO 14971, FDA biocompatibility guidance, and Regulation (EU) 2017/745.

The role applies specialized medical-device biocompatibility knowledge throughout the product lifecycle, interprets requirements for Class II and Class III devices, and develops evaluation strategies for product development and change management. The scientist reviews scientific information, identifies gaps, assesses project risks, and recommends mitigation strategies. The position has no direct people-management responsibilities.

The role is based in a fast-paced, collaborative environment and involves preparing scientific and regulatory documentation, supporting submissions, monitoring changes to standards and regulations, and working with colleagues in analytical chemistry, toxicology, and preclinical safety. The stated work setting includes clean, well-lit, temperature-controlled production areas. Travel is not required.

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 the ability to apply increasingly complex scientific knowledge and techniques.
• Expert-level ability to explain and teach experimental approaches, protocols, and scientific methods, including experimental design and data interpretation.
• Knowledge of regulations and standards affecting IVDs and biologics.
• Basic computer skills and ability to learn new computer programs.
• Proficiency with MS 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 as part of a team and independently in a fast-paced, changing environment.
• Ability to prioritize work, complete deliverables on time, and meet deadlines.
• Strong organizational and follow-up skills and 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, extractables and leachables analysis, medical device manufacturing processes, and biocompatibility assessment methodology.
• Experience writing biological risk assessments for 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 in accordance with 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 to determine whether data adequately address 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 biological safety concerns.
• Maintain knowledge of applicable standards and industry requirements, including updates and revisions to ISO 10993, ISO 14971, FDA guidance, and other relevant regulations.
• Perform or assist with gap assessments following updates to standards, regulations, or guidance; identify potential deficiencies and recommend actions to maintain compliance and minimize business impact.
• Contribute to biological evaluation strategies with colleagues in analytical chemistry, toxicology, and preclinical safety, as applicable.
• Comply with Abbott policies, procedures, and quality system requirements.
• Prepare, edit, and finalize biological evaluation 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

• Career development opportunities with an international company.
• Employees may qualify 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.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit offering an affordable and convenient path to a bachelor’s degree.
• Training and career development, including onboarding programs for new employees and tuition assistance.
• Competitive compensation, incentives, and retirement plans.
• Medical, dental, vision, wellness, and occupational health programs.
• Paid time off.
• 401(k) retirement savings with a company match.

What This Job Offers

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