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 of . + Free medical coverage for employees* via the Health Investment Plan (HIP) PPO + An excellent retirement savings plan with 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 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. Our location in **Westford, MA** currently has an opportunity for an **Associate So** **ftware Quality Design Engineer** **.** **THIS IS AN ON-SITE DAILY ROLE.** **The Opportunity** This position works out of our Westford, MA location in the Abbott Vascular Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. **WHAT YOU'LL DO** + Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA, Cybersecurity Risk Assessment) + Support on-time execution of Quality Plans + Guide development and documentation of standard operating procedures, specifications and test procedures + Support product recertifications + CAPA management – including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria. + Work within Agile software development lifecycle framework + Support usability and human factors engineering reviews + Coach and mentor team members on best practices in design quality, and overall product lifecycle testing/quality engineering to establish product and system reliability. Accent on agile testing and automated testing practices + Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection + Review and approve test methods, protocols and test results provided by another functional group. + Support activities related to software change management and overall change management + Bring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities + Support all activities, as needed by the business within the software development lifecycle. + Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps + Support internal & external audit and related responses + Support the establishment of objective, measurable and verifiable customer and product requirements + 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. + Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Perform other related duties and responsibilities, on occasion, as assigned. **EDUCATION AND EXPERIENCE YOU’LL BRING** + Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience. + **Minimum of 0-2+ years of combined experience in software design quality, cybersecurity design quality is REQUIRED** + **Medical Devices experience in Software is REQUIRED** + **Risk Management experience is REQUIRED** + **Experience with ISO 14971 is REQUIRED** + **FMEA experience is REQUIRED** **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 history of being actively involved in local communities Apply Now (https://www.jobs.abbott/us/en) * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. **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 Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $48,000.00 – $96,000.00. 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