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.

EPHF

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives. 

WHAT YOU’LL DO 

A Senior Design Assurance Engineer - provides ownership of the Design Control deliverables required to support both new product development projects and design change projects

• Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of
• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
• Lead Risk Management activities from product Concept through Commercialization
• Support design test and inspection method development, and lead method validation activities
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
• Support and ensure internal & external audit responses and on-time product re-certifications
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
• Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
• Develop and lead other team members
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Performs other related duties and responsibilities, on occasion, as assigned

EDUCATION AND EXPERIENCE YOU’LL BRING 

• Bachelor level degree in Engineering or Technical Field; advanced degree preferred
• 5-8+ years Quality engineering experience with new product development and demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, and ISO 13485
• Solid communication and interpersonal skills
• Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Advanced computer skills, including statistical/data analysis and report writing skills
• Prior medical device experience preferred
• ASQ CQE certification preferred
• Design for Six Sigma and Critical to Quality training and experience preferred
• Experience working in a broader enterprise/cross-division business unit model preferred
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely, proactive manner
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel approximately 10%, including internationally
• Ability to maintain regular and predictable attendance

WHAT WE OFFER  

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

• 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 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:  www.abbottbenefits.com  

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.