Sr. Biocompatibility Scientist

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Job Description Summary We are seeking an experienced, high caliber Scientist II who will make an important contribution to patient safety by supporting projects and programs related to the biocompatibility of medical devices, materials, and processes. This role will be responsible for submitting test devices to laboratories, managing test progress, and serving as the primary contact for the labs. The Scientist II will work closely with cross-functional teams to provide biocompatibility deliverables (biocompatibility plans/reports/justifications) in compliance with global regulatory requirements such as ISO 10993. The role requires comprehensive knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance affecting assigned devices (Class I to Class III). The candidate must be able to support the biocompatibility team in correctly apply regulatory requirements as appropriate to product development and change activities for assigned devices. The candidate must have strong ability to interpret biological test results and detailed scientific information. Essential Responsibilities: Develop technically sound protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers. Support quality system activities, including updating procedures and templates to ensure compliance with regulatory requirements and continuous improvement initiatives. Understand biocompatibility strategies that address gaps in materials, design and processes to achieve optimal solutions that satisfy cost and technical requirements related to biological safety. Monitor biocompatibility testing activities to ensure that studies are conducted according to the study protocols, SOPs, applicable regulations and the principles of Good Laboratory Practices (GLP). Make positive contributions to and recommend approaches for updating and developing procedures for internal and external guidance documents related to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA). Assist the biocompatibility team members in identifying critical process factors and their effects on biological safety. Support biological hazards risk analysis activities. Interface with key business partners internally and externally. Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations. Assist biocompatibility team members in developing strategies and drafting responses to regulatory submission questions related to biocompatibility. Required Qualifications: Associates Degree ((± 13 years) Minimum 4 years experience Preferred Qualifications Bachelor's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or other medical-related disciplines. Master in Science (MS) degree preferred. 3+ 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 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. 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 and meet deadlines in a timely manner. 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. The base pay for this position is $78,000.00 – $156,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Research and Discovery DIVISION: MD Medical Devices LOCATION: United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No 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) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: 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. Follow Us: Facebook LinkedIn YouTube Twitter