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 TitleStaff Biocompatibility ScientistAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition 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.The Opportunity This position works out of our Santa Clara, CA location in the Abbott Vascular division. This role may be hired from any other Abbott location in the United States.Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.What You'll Work OnConduct safety assessment for new product development and provide solutions for the evaluation of safety risk for manufacturing and life cycle management challengesServe as the key impact assessor for any product changes either post biocompatibility testing or post market approval and execute/coordinate mitigation plan per the assessment.Serve as core team project memberAuthor and provide guidance on risk assessments (products/materials, impurities, leachables and extractables) and author regulatory documents and response to inquiries from Regulatory Authorities.Responsible for meeting scope and timelines of Biocompatibility deliverables to project teamsReview, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility and appropriate Regulatory and Quality compliance.Development and maintenance of biocompatibility documents to support EU Medical Device Regulations (MDR) Technical FilesMentor junior staff or contractorsCollaborate and clearly communicate with internal and external stakeholders (e.g., Board Certified Toxicologists and Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testingIn depth understanding of US and global regulations, particularly ISO 10993, and requirements for biocompatibility testingInvestigates the feasibility of applying scientific principles and concepts to potential technologies, materials, processes and productsMaintains substantial knowledge of state-of-the-art principles and theories and contributes to scientific literature and conferencesParticipates in intellectual property evaluations and development of patent applicationsConsults and interacts with outside and inside expertsMay coordinate interdepartmental activities and research effortsWrite and submit professional articles for technical journalsUnderstands business environment and relates extensive knowledge of internal and external technological activities to trendsInterfaces with senior management on significant matters, often requiring the coordination of activity across organizational unitsParticipates in the development of other technical contributors by facilitating training and providing feedback and guidanceMay lead a project teamProvides technical leadership to business unitsActs as a mentor to less-experienced staff and may provide work direction or supervise other technical employeesExercises judgment independentlyPlans and organizes project assignments of substantial variety and complexityInitiates or maintains schedule for projects and project milestonesEstablishes priorities of individual or project assignmentsSelects methods and techniques to lead a project to completionErroneous decisions or recommendations would typically result in failure to achieve major organizational objectivesAbility to lead multiple projects, managing priorities and resource management Experience in the planning and implementation of studies in the areas of residue analysis, toxicology and/or the biocompatibility of medical devices.Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).Experience in managing studies at external facilitiesExperience working in Design Control environmentStrong computer and general software skillsStrong oral/written communication skillsPersonal qualities such as a talent for organization, initiative, reliability, customer orientation, decision-making capacity and the ability to think and work in an interdisciplinary mannerRequired QualificationsBachelor's degree in biology, biochemistry, toxicology, analytical chemistry or materials scienceor similar engineering discipline or an equivalent combination of education and work experience.Minimum 9 years related work experience with a complete understanding of specified functional areaPreferred QualificationsMaster or PhD degree or equivalent in biology, biochemistry, toxicology, analytical chemistry or materials science, preferably with experience in medical device industryApply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $104,300.00 – $208,500.00. In specific locations, the pay range may vary from the range posted.Job SummaryJob number: 31056175Date posted : 2023-06-29Profession: Research & DevelopmentEmployment type: Full time
