Senior Design Quality Engineer

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. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow & 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 high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor, and manage heart failure, allowing people to restore their health and get on with their lives. We are seeking an experienced Sr. Design Quality Engineer to ensure our medical devices are developed in accordance with Abbott’s design control requirements and state-of-the-art product standards. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced, and progressive. We value people with great ideas who partner with others both internally and externally to accomplish goals. This position works out of our Atlanta, GA or Pleasanton, CA location in the Heart Failure division and is an ONSITE position. What You’ll Work On The Sr. Design Quality Engineer will serve as a technical representative providing design quality expertise to product development teams and is responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient / user safety, customer satisfaction, and organizational success. What You’ll Do Lead and/or support on-time completion of Design Control deliverables for both new product development projects and design change projects. Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements. Support design verification and validation planning & execution, including any cross-functional investigation and resolution activities. Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps. Lead risk management activities from product concept through commercialization. Support test method development and lead test method validation activities. Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications. Support biocompatibility and sterilization qualifications. Support audits and quality system improvement activities. Comply with Abbott, U.S. FDA, EU MDR, and other requirements, as applicable. Education and Experience You’ll Bring Required Bachelor’s degree in Engineering or Technical Field. Minimum of 5 years of experience in medical device Quality Engineering, Research & Development, or Process / Manufacturing Engineering with experience supporting product development. Experience in test method development and validation. Experience in preparing risk assessments, FMEA, and other risk documents. Preferred Advanced degree in Biomedical Engineering or related discipline. Experience in active implantable medical devices. Experience in electro-mechanical medical devices and associated regulations / standards. Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA). Working knowledge of statistics and its application to verification and validation. Experience with software verification and validation activities, including test case protocols and reports and software development plans. The base pay for this position is $72,700.00 – $145,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: HF Heart Failure LOCATION: United States > Atlanta : 387 Technology Circle NW Suite 500 ADDITIONAL LOCATIONS: United States > Pleasanton : 6101 Stoneridge Dr WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf 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. Follow Us: Facebook LinkedIn YouTube Twitter

Salary : $72,700 - $145,300