Senior Manager, Design Transfer

Job description

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

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.

Responsibilities

• 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 risk management methodologies.

Requirements

• A Bachelor's degree in a scientific, engineering or related discipline.
• Progressive experience within the medical device industry.
• Leadership or management experience.
• Strong knowledge of medical device regulations and quality systems, including FDA regulations, ISO 13485 and risk management principles.
• Extensive experience in product development lifecycles, design controls, design transfer, process validation and change management.
• Proven experience leading complex cross-functional projects across multiple sites and stakeholders.
• Strong understanding of manufacturing processes, quality systems and product commercialization activities.
• Excellent communication, relationship-building and stakeholder management skills.
• The ability to influence at all levels of the organisation and drive results in a fast-paced global environment.
• Experience working with contract manufacturers, large-scale product transfers and global supply chains would be highly advantageous.