Senior Manager, Design Transfer

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 risk management methodologies.

This is a unique opportunity to influence the future of Abbott's Diabetes Care business while leading global initiatives that directly impact products used by millions of people every day.

We're looking for an experienced quality and design transfer leader with a passion for innovation, collaboration and delivering excellence in a highly regulated environment.

To be successful, you will bring:

• 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.

In specific locations, the pay range may vary from the range posted.