{"schemaVersion":"jobsearcher.job.v1","id":"b4c154b410efa1663abdcbcf","url":"https://jobsearcher.com/jobs/b4c154b410efa1663abdcbcf","canonicalUrl":"https://jobsearcher.com/jobs/b4c154b410efa1663abdcbcf","title":"Software Design Quality Engineer","description":"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 115,000 colleagues serve people in more than 160 countries.\n\n*This is not an active open requisition. We are building a candidate slate for a future opening.*\n\nJob Title\n\nSoftware Design Quality Engineer\n\nWorking at Abbott\n\nAt 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:\n\nCareer development with an international company where you can grow the career of which you dream.\n\nEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.\n\nAn excellent retirement savings plan with high employer contribution\n\nTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.\n\nA 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.\n\nA 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.\n\nTHE OPPORTUNITY\n\nWe currently have an opening for a Software Design Quality Engineer for the Vascular division. This role is located at our Westford, MA location. This is a fully onsite role.\n\nAbbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.\n\nMAIN RESPONSIBILITIES\n\nLead, 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)\n\nSupport on-time execution of Quality Plans\n\nGuide development and documentation of standard operating procedures, specifications and test procedures\n\nSupport product recertifications\n\nCAPA 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.\n\nWork within Agile software development lifecycle framework\n\nSupport usability and human factors engineering reviews\n\nCoach 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\n\nParticipate in reviews for System and Software requirements, Software and Firmware design, and code inspection\n\nReview and approve test methods, protocols and test results provided by another functional group.\n\nSupport activities related to software change management and overall change management\n\nBring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities\n\nSupport all activities, as needed by the business within the software development lifecycle.\n\nEnsure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps\n\nSupport internal & external audit and related responses\n\nSupport the establishment of objective, measurable and verifiable customer and product requirements\n\nComplete document Change Request reviews in a timely and objective manner\n\nAdditional duties may be identified by functional management based on the current project/business objectives.\n\nSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.\n\nComply 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.\n\nPerform other related duties and responsibilities, on occasion, as assigned.\n\nEDUCATION AND EXPERIENCE YOU’LL BRING\n\nREQUIRED EXPERIENCE\n\nBachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.\n\nMinimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality\n\nExperience ensuring automation frameworks and scripts meet design control requirements\n\nExperience with software configuration, and issue tracking tools and requirements tools such as Jira and Jama\n\nExperience as team-member/lead in Agile SDLC projects/programs\n\nDeep knowledge of various types of SDLC’s (V-Model, Iterative, Agile/Scrum, etc.)\n\nExperience working in a broader enterprise/cross-site business unit model\n\nWorking knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485\n\nAbility to work in a highly matrixed and geographically diverse business environment.\n\nAbility to work within a team and as an individual contributor in a fast-paced, changing environment\n\nAbility to work in a lab, and hands-on experience with medical device development\n\nAbility to leverage and/or engage others to accomplish projects\n\nStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization\n\nAbility to multitask, prioritize and meet deadlines in timely manner\n\nStrong organizational and follow-up skills, as well as attention to detail\n\nPREFERRED EXPERIENCE\n\nMaster’s level degree preferred\n\nASQ CSQE and ISTQB certifications desired\n\nExperience working with test management tools such TestComplete, desired\n\nExperience in code review/static analysis tool(s) to aide code review such as Coverity, desired\n\nProgramming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desired\n\nClinical/Hospital experience desired\n\nExperience in software testing and verification/validation, including lead experience, desired\n\nApply Now\n\nLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com\n\nFollow 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.\n\nConnect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.\n\nThe base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.","company":"Abbot","rawCompany":"abbot","city":"Westford","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-28T10:18:17.354Z","occupations":[{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"}],"industries":[{"code":"513210","title":"Software Publishers","slug":"software-publishers"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"541511","title":"Custom Computer Programming Services","slug":"custom-computer-programming-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Software Design Quality Engineer","description":"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 115,000 colleagues serve people in more than 160 countries.\n\n*This is not an active open requisition. We are building a candidate slate for a future opening.*\n\nJob Title\n\nSoftware Design Quality Engineer\n\nWorking at Abbott\n\nAt 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:\n\nCareer development with an international company where you can grow the career of which you dream.\n\nEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.\n\nAn excellent retirement savings plan with high employer contribution\n\nTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.\n\nA 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.\n\nA 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.\n\nTHE OPPORTUNITY\n\nWe currently have an opening for a Software Design Quality Engineer for the Vascular division. This role is located at our Westford, MA location. This is a fully onsite role.\n\nAbbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.\n\nMAIN RESPONSIBILITIES\n\nLead, 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)\n\nSupport on-time execution of Quality Plans\n\nGuide development and documentation of standard operating procedures, specifications and test procedures\n\nSupport product recertifications\n\nCAPA 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.\n\nWork within Agile software development lifecycle framework\n\nSupport usability and human factors engineering reviews\n\nCoach 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\n\nParticipate in reviews for System and Software requirements, Software and Firmware design, and code inspection\n\nReview and approve test methods, protocols and test results provided by another functional group.\n\nSupport activities related to software change management and overall change management\n\nBring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities\n\nSupport all activities, as needed by the business within the software development lifecycle.\n\nEnsure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps\n\nSupport internal & external audit and related responses\n\nSupport the establishment of objective, measurable and verifiable customer and product requirements\n\nComplete document Change Request reviews in a timely and objective manner\n\nAdditional duties may be identified by functional management based on the current project/business objectives.\n\nSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.\n\nComply 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.\n\nPerform other related duties and responsibilities, on occasion, as assigned.\n\nEDUCATION AND EXPERIENCE YOU’LL BRING\n\nREQUIRED EXPERIENCE\n\nBachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.\n\nMinimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality\n\nExperience ensuring automation frameworks and scripts meet design control requirements\n\nExperience with software configuration, and issue tracking tools and requirements tools such as Jira and Jama\n\nExperience as team-member/lead in Agile SDLC projects/programs\n\nDeep knowledge of various types of SDLC’s (V-Model, Iterative, Agile/Scrum, etc.)\n\nExperience working in a broader enterprise/cross-site business unit model\n\nWorking knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485\n\nAbility to work in a highly matrixed and geographically diverse business environment.\n\nAbility to work within a team and as an individual contributor in a fast-paced, changing environment\n\nAbility to work in a lab, and hands-on experience with medical device development\n\nAbility to leverage and/or engage others to accomplish projects\n\nStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization\n\nAbility to multitask, prioritize and meet deadlines in timely manner\n\nStrong organizational and follow-up skills, as well as attention to detail\n\nPREFERRED EXPERIENCE\n\nMaster’s level degree preferred\n\nASQ CSQE and ISTQB certifications desired\n\nExperience working with test management tools such TestComplete, desired\n\nExperience in code review/static analysis tool(s) to aide code review such as Coverity, desired\n\nProgramming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desired\n\nClinical/Hospital experience desired\n\nExperience in software testing and verification/validation, including lead experience, desired\n\nApply Now\n\nLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com\n\nFollow 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.\n\nConnect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.\n\nThe base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.","datePosted":"2026-08-28T10:18:17.354Z","dateModified":"2026-08-28T10:18:17.354Z","hiringOrganization":{"@type":"Organization","name":"Abbot","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Westford","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b4c154b410efa1663abdcbcf"},"url":"https://jobsearcher.com/jobs/b4c154b410efa1663abdcbcf"}}