Senior Biocompatibility Scientist II

Abbott•Santa Clara, CA

1d•$100,000 - $200,000•Onsite

About The Position

As a Senior 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 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, including but not limited to the ISO 10993 series of standards, ISO 14971, FDA Biocompatibility Guidance, and Regulation (EU) 2017/745. You will leverage your 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, identify gaps, 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.

Requirements

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 deliverables in 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.
Bachelors Degree (± 16 years) biological or physical sciences, or mathematics OR Masters Degree (± 18 years) with 2 years of experience OR Doctorate Degree (± 19 years) with 2 years of experience.
7 + years of progressively responsible positions in a research development environment or PhD with 2 years of experience.
Execution of practical lab skills with increasing complexity of knowledge with experience. Demonstrates knowledge of science and the ability to apply more complex and advanced principles and techniques with experience. Expert level (able to explain and teach) experimental approaches/protocols and scientific methods such as designing experiments and interpreting data. Knowledge/use of regulations and standards affecting IVDs and Biologics.
Basic computer skills - able to learn new computer programs.

Nice To Haves

Bachelor's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or related discipline.
Advanced degree (MS or PhD) preferred.
5+ 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.

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, ensuring timely completion of tasks to meet project schedules.
Analyze biocompatibility test results to determine data adequacy for biological effects; troubleshoot unexpected results using problem-solving skills and technical knowledge.
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.
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 and assist with gap assessments when standards, regulations, or guidance are updated to identify potential deficiencies in previous evaluations relative to 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 with Abbott policies, procedures, and quality system requirements.
Prepare, edit, and finalize biological 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.

Benefits

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, 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 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
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