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 113,000 colleagues serve people in more than 160 countries.

PRINCIPAL DESIGN QUALITY ENGINEER

Lake Forest, IL

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 107,000 colleagues serve people in more than 160 countries

About Abbott

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our Lake Forest, IL location currently has an opportunity for a Principal Design Quality Engineer within our Cardiometabolic & Informatics business unit. This role is responsible for maintaining a strong collaborative partnership with cross-functional product development teams. To ensure that our diagnostic instruments and assays are designed following product requirements and meet their intended use while delivering the safest experience possible to our patients. This role spans the full range of product development through commercialization and on-market design changes. 

WHAT YOU’LL DO

• Responsible for world-class design controls
• Deliver Holistic & Strategic Design Verification/Validation Strategies with emphasis on ensuring no issues escape the Development Process
• Drive efficient and cost-effective solutions
• Led complex design plan activities, set strategy for design control deliverables
• Ensure DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps
• Support design, test, inspection method development, and lead method validation activities
• Lead Risk Management (FMEA) activities from product concept through commercialization
• Lead and Document: design failure, root cause investigations, corrective, preventive action (CAPA) activities, and perform statistical analysis on complex problems
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Present to senior leaders on significant matters
• Work closely with Operations, R&D, and Quality teams across multiple global manufacturing sites and locations to identify and action areas of opportunity.
• Strong project management skills, able to multi-task and set priorities to meet overall business objectives
• Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives, including up to 20% travel (domestic and international)

 EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s degree Required - Engineering, Science or technical discipline
• Minimum 8 years of IVD/Medical device system integration experience and knowledge in Design Control requirements
• Detailed knowledge in design control, RCA, validation life-cycle including requirements definition, FMEA, CAPA, specification, and other quality system elements

Preferred

• Advanced degree preferred
• Ability to work within a team and as an individual contributor in a fast-paced and constantly changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Strong project management skills. 
• Must be self-motivated and able to inspire others. You have a proven ability to create strategy and tactics, delivering results within business constraints.
• Multitasks prioritizes, and meets deadlines on time. Strong organizational and follow-up skills, as well as attention to detail.
• Strong statistical background with Six Sigma Blackbelt or ASQ CQE certification preferred. 
• Knowledge and experience in the application of design control and reliability analysis (i.e., life-cycle predictions, modeling, DOE, environmental and stress testing, etc.) preferred
• Additional 5+ years applicable experience in equipment/packaging, system engineering, quality, project management, or related field preferred

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives, and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and a history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.