Senior Biocompatibility Scientist II

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 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Senior Biocompatibility Scientist II Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. • 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Temecula, CA for our Medical Device business. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.    What You’ll Work On 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.    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 equivalenc