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. **Engineer II** **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with a high employer contribution + Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree. + A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. 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. **The Opportunity** Our **_Design Assurance Engineer II_** assures new or modified products conform to requirements and establish compliance with the quality system. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. **What You’ll Work On** + Execute and support on-time completion of Design Control Deliverables + Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects + Accountable for Design Verification and Validation planning & execution, statistical analysis, including active cross-functional root-cause analysis investigation & resolution activities + Lead or support Risk Management activities from product Concept through Commercialization + Support design test and inspection method development, and lead method validation activities + Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps + Support manufacturing process development & qualification for new product commercialization and product changes + Support internal & external audit responses + Support product re-certifications + Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements + Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications + Support execution of biocompatibility and sterilization qualifications + Complete Document Change Request Reviews in a timely and objective manner + Additional duties may be identified by functional management based on the current project/business objectives. + 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. **Required Qualifications** + Bachelor level degree in Engineering or Technical Field + 2-5 years’ experience + Previous Quality engineering experience and demonstrated use of Quality tools/methodologies + Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization + 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. + Multitasks, prioritizes and meets deadlines in timely 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. **Preferred Qualifications** + Prior medical device experience preferred + Experience working in a broader enterprise/cross-division business unit model + ASQ Certified Quality Engineer / Six Sigma Green Belt Certification + Working understanding of FDA, GMP, and ISO 13485 + Working understanding of the following standards 60601, 62304, &/or 14971 Apply Now (https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) 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. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on X @AbbottNews. The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com