Abbott
Senior Biocompatibility Scientist II
United States - California - Santa Clara · Senior
Sponsorship not specified$100k-$200kDetected 3 hours ago
Product ManagementExcelHRISFDA RegulatoryMedical DevicesResearchAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingWritingMicrosoft OfficeSharePoint
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About the role
- 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.
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.
- 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
- Prepare, edit, and finalize biological evaluation safety plans, test protocols, lab reports, evaluation reports, synopses, regulatory submission content, and related biocompatibility documents.
- 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.
- Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
- United States > Santa Clara: Building B - SC
Requirements
- 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.
- Demonstrates knowledge of science and the ability to apply more complex and advanced principles and techniques with experience.
- Knowledge/use of regulations and standards affecting IVDs and Biologics.
- Skills and Abilities Required:
Nice to have
- Bachelor's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or related discipline.
- Advanced degree (MS or PhD) preferred.
- A master's degree or PhD in a relevant engineering or scientific discipline may substitute for years of industry experience.
- Role level may be adjusted to Senior Biocompatibility Scientist II based on candidate qualifications.
Skills
- 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 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.
- Abbott is a global healthcare leader that helps people live more fully at all stages of life.
- Our 115,000 colleagues serve people in more than 160 countries.
Compensation
- Financial security through competitive compensation, incentives and retirement plans
Benefits
- 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
- 401(k) retirement savings with a generous company match
- Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
- MD Medical Devices
Company info
- What We Offer At Abbott, you can have a good job that can grow into a great career.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- At Abbott, you can have a good job that can grow into a great career. We offer:
Equal opportunity
- 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
- Equal Opportunity Employer, committed to employee diversity.
This listing is sourced directly from Abbott's careers page and normalized into a canonical job model.