Senior Manager, Design Transfer

Thornton Tomasetti; Minster Lovell; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Bonus opportunity

Private healthcare

Defined contribution pension

Life assurance

Job summary

Abbott Diabetes Care in the United Kingdom seeks a Senior Manager of Design Transfer to oversee the transfer of glucose monitoring products from R&D into manufacturing. You will collaborate with Quality, Operations, Engineering, Regulatory Affairs and R&D to ensure compliant, on-time launches for millions of users worldwide.

The role requires proven leadership in medical devices, deep knowledge of FDA/ISO 13485, and experience with contract manufacturing.

Qualifications

• Bachelor's degree in a scientific, engineering or related discipline.

Responsibilities

• Lead strategy, planning and execution of design transfer activities for new products, changes and manufacturing improvements.
• Drive commercialization of diabetes care technologies from development to global manufacturing operations.
• Partner with cross-functional and cross-site stakeholders to ensure successful product launches and business continuity.
• Ensure compliance with Abbott Quality Systems and regulatory requirements (FDA, ISO 13485).
• Support selection and onboarding of Abbott and external manufacturing sites for product transfers.
• Lead validation strategies including process validation, test method validation and manufacturing qualification.
• Drive continuous improvement to enhance product quality, operational performance and regulatory compliance.
• Provide leadership and technical guidance across quality engineering and project teams.
• Act as SME during regulatory inspections and quality audits.
• Manage risk using DFMEA, PFMEA and other risk management methods.

Skills

Design transfer leadership

Regulatory compliance

Cross-functional leadership

Product development lifecycle

Quality systems (FDA ISO 13485)

Process validation

Change management

Contract manufacturing experience

Education

Bachelor's degree in science or engineering

Job description

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.

• 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.

ABOUT YOU:

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.

WHAT WE OFFER:

This is an opportunity to take on a strategic leadership role within one of the world's leading medical technology organisations. You will work alongside talented colleagues across Quality, R&D, Operations and Regulatory Affairs while helping to bring life-changing healthcare technologies to patients around the world. Abbott offers a benefits platform that provides security to you and your family. As you'd expect from an innovative global healthcare company, we offer a competitive salary, bonus opportunity, a class-leading defined contribution pension scheme, private healthcare, life assurance, flexible benefits and extensive opportunities for professional development and career progression. At Abbott, you'll be empowered to make a meaningful difference while developing your leadership career within a business that is shaping the future of healthcare.

The base pay for this position is N/A

JOB FAMILY: Operations

QUALITY DIVISION: ADC Diabetes Care

LOCATION: United Kingdom > Witney : Range Road

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 5 % of the Time

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable

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. 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 novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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