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 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 ofEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar yearAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degreeA company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by FortuneA company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

The Director of Design Transfer is responsible for directing a team of quality engineers focused on validation and design transfer of products and processes, into Diabetes Care manufacturing facilities and Third-Party Manufacturers. Products include sensor components, finished sensor medical devices, strips, meters, and readers for the Diabetes Care business unit. This position also directs and coordinate's introduction of new products as well as changes to the on-market products and related activities to transfer into manufacturing. This position will also be responsible for effective transfer of test methods and test method validation for complaint investigation for New Products and changes to on market products.

 

This role will provide oversight and management for the technical quality organization, ensuring that the quality system requirements for design, validation and qualification for product development and production are effectively established and maintained according to business needs while meeting regulatory requirements.

 

Work effectively with other departments, especially engineering teams, R&D Product development, R&D Systems Engineering, Regulatory Affairs, Complaint Investigations to define requirements and drive quality excellence of products, including design documents review, product quality metrics defining and review, design reviews, processes/practices simplification, QMS training, etc.

This leadership role relies on extensive experience and judgment to plan and accomplish goals, performs a variety of tasks, leads and directs the work of others, and a wide degree of creativity and latitude is expected.

Overall, this Director is responsible for:

Quality assurance activities for sensor, strip, meter and reader design transfer for health care products, including both medical and non-medical applications.Creating and maintaining an efficient, highly motivated, quality engineering organization.

 

What You’ll Work On

Provides strategic leadership in directing and overseeing the transfer of all new products and product changes from R&D into Manufacturing Operations including completion of commercialization activities to launch new products according to division goals.Exercise leadership in a multidisciplinary environment to expedite, manage, and coordinate a multitude of interrelated activities within the constraints of limited resources and changing priorities.Develop, implement and improve quality processes and procedures, automated systems and reporting systems.Develop program strategies for product transfer. Serve as the key interference with R&D to Manufacturing Operations, Quality and other cross functional leadership for product transfer and change management.Supports continuous product and process improvement through identifying major site quality risks and product quality metrics; leverages metrics to assist in shaping the strategy of the quality engineering department.Work effectively with other departments, especially engineering teams, to define requirements and drive quality excellence of products, including design documents review, product quality metrics defining and review, design reviews, processes/practices simplification, QMS training, etc.Ensures that product validation and design activities are handled in a manner that complies with all pertinent regulatory requirements Reports on the performance of the design/validation activities within the quality system. Serves as the subject matter expert on validation processes for external regulatory inspections and audits.Coordinate input from R&D and cross-functional division leadership from Manufacturing Operations, QC, QA, Clinical Affairs, Planning, Purchasing, Validations, and Regulatory on related projects or sub-projects to increase resource efficiencies and reduce product cost through close collaboration.Directs the Quality Engineering group, providing mentoring, technical guidance and career growth planning.Market and Technology Awareness: Staying informed about the latest trends, technologies, and regulations in the med tech industry to inform design transfer strategies.Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts.Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process, including on-market risk evaluation and assessments. Making decisions on whether or not to take action on market to remedy non-conforming product on-market.Complies with worldwide regulations, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Decision and recommendations made by this position have a direct impact on marketed items for domestic and international sales.Assure line of communication with DVP QA and Senior Leaders on critical quality issues that may result in potential business interruption.Assure business continuity in leadership positions and critical roles through talent management planning and development.

Ability to travel, including internationally 50% of time.

Required Qualifications

Bachelor’s Degree required in Engineering, Computer Sciences or related fieldMinimum 12 years of progressive work experience in software related medical device or high technology industriesMinimum 10 years of prior management experienceTechnical background and direct experience of product / process validation and design transfer activities for leading edge medical devicesDemonstrated experience in working effectively to ensure quality and compliance requirements are designed/built into the productsDemonstrated understanding of product development lifecycles, design change and change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicingDemonstrated ability to understand/ familiarity with applicable FDA, European and other relevant clinical/regulatory requirements, including ISO 13485, IVDR/MDR, 21CFR 820 Quality System Regulation, MDSAPStrong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business resultsStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Preferred Qualifications

Master’s Degree in a technical discipline preferredMedical device background in a Quality Leadership roleExperience in validation methodologies and principles for manufacture of medical devices is preferredExperience in a globalized working environmentProven project management skills with demonstrated analytical problem solving skills and ability to create relationships, influence and move critical projects forward in alignment with key stakeholdersExperience working in a broader enterprise/cross division business unit model preferredAbility to work in a highly matrixed and geographically diverse business environmentAbility to work effectively within a team in a fast-paced changing environment

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Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is $193,300.00 – $386,700.00. In specific locations, the pay range may vary from the range posted.