Senior Manager, Design Transfer

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About the role

JOB DESCRIPTION: Senior Manager, Design Transfer Location: Witney 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. Joining us, you can shape your career as you shape the future of healthcare. 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 breakthrough medical technologies, we are advancing some of the most innovative healthcare solutions available today. ABOUT OUR DIABETES CARE DIVISION: World Leader in Glucose Monitoring , Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems for use in both home and hospital settings. Our technologies are transforming the way people manage diabetes, including the revolutionary FreeStyle Libre portfolio, which has helped redefine glucose monitoring for millions of users around the world. Through continued investment in innovation, manufacturing excellence and world-class quality systems, Abbott Diabetes Care remains at the forefront of healthcare technology, delivering solutions that help people live healthier, fuller lives. THE OPPORTUNITY: At Abbott Diabetes Care, our technologies are transforming the lives of millions of people living with diabetes worldwide. As our portfolio continues to expand across the FreeStyle Libre family, Blood Glucose Monitoring Systems, medical device combination products and emerging digital health technologies, we have an exciting opportunity for a Senior Manager, Design Transfer to join our Quality organisation. In this highly visible leadership role, you will be responsible for overseeing the design transfer of products that will reach more than 15 million customers globally and support a business delivering in excess of $10 billion in revenue over the next five years. You will lead the successful transfer of new product introductions, design changes, validation activities and quality processes from Research & Development into manufacturing operations across Abbott sites and external manufacturing partners. Working at the intersection of Quality, Operations, Engineering, Regulatory Affairs and R&D, you will play a critical role in bringing innovative healthcare technologies to market while ensuring compliance with global regulatory requirements and Abbott quality standards. Key responsibilities include: • Leading the strategy, planning and execution of design transfer activities for new products, product changes and manufacturing improvements. • Driving the commercialization of innovative diabetes care technologies from development into global manufacturing operations. • Partnering with cross-functional and cross-site stakeholders to ensure successful product launches and business continuity. • Ensuring compliance with Abbott Quality Systems and external regulatory requirements, including FDA and ISO standards. • Supporting the selection and onboarding of Abbott and external manufacturing sites for product transfers. • Leading validation strategies, including process validation, test method validation and manufacturing qualification activities. • Driving continuous improvement initiatives to enhance product quality, operational performance and regulatory compliance. • Providing leadership, coaching and technical guidance across quality engineering and project teams. • Acting as a key subject matter expert during regulatory inspections and quality audits. • Managing risk through the application of tools such as DFMEA, PFMEA, Fault Tree Analysis and other

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