{"schemaVersion":"jobsearcher.job.v1","id":"4a644d5842e52a330e34cae9","url":"https://jobsearcher.com/jobs/4a644d5842e52a330e34cae9","canonicalUrl":"https://jobsearcher.com/jobs/4a644d5842e52a330e34cae9","title":"Manager, Software Design Quality Engineering","description":"Johnson & Johnson is currently recruiting for Manager, Software Design Quality Engineering! This position will be located in Danvers, MA!\n\nAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\n\nPosition Summary:\nThe Software Design Quality Engineering Manager leads a team utilizing Software Design Quality Engineering, and Risk Management techniques and expertise to provide management and functional support for the entire software development life cycle (SDLC) of Abiomed’s software products. This position also supports company compliance with applicable federal, industry, and corporate procedures, guidelines, and regulations during the design, development, test, and installation of software products and the software aproducts for US and ROW.\n\nPrimary Duties and Responsibilities:\nLead Software Design Quality Engineering team in support of Abiomed’s Product Development and Software Development Life Cycle processes for various medical device projects. Including Software in Medical Device (SiMD), MDDS, CDS, IoT, Multi-function devices, and SaMD projects.\nAccountable for the Software Risk Management, Software Development Lifecycle, Design Control, and Change Control processes.\nRepresent the Software Design Quality Engineering function in Notified Body and Regulatory body audits/inspections\nDesign and implement process improvements for the Software Design Quality Engineering function, in areas such as design controls, change control, risk management, and software anomaly tracking.\nDefine and communicate overall objectives for the Software Design Quality team.\nManage long and short-term planning for the Software Design Quality Engineering team, including training, development, and goal setting.\nBuild and maintain strong interpersonal relationships within and outside of the business unit.\nSupport and ensure adherence to Abiomed’s product cybersecurity processes.\nEnsure robust processes are employed in new product development.\nProvide input and leadership for Quality policies, approaches, and standard practices.\nSupport maintaining alignment with US and International regulations and standards, as well as Abiomed quality systems.\nIdentify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), EU MDR, ISO 13485, ISO 14971, IEC 62304, etc.\n\nQualifications\nEducation:\nBachelor’s degree in sciences or engineering with minimum 8 years in quality desired with at least 2 years in a leadership role\nRequired:\nMust have software quality experience working with and on Software Safety Class C medical device products, FDA Class III or II medical devices\nExperience with Domestic and International regulatory requirements and working with regulating bodies.\nWorking knowledge and practical application of relevant requirements of 21 CFR Part 820, EU MDR, ISO and IEC standards\nStrong leadership skills with demonstrated ability to create momentum and deliver excellent results.\nAbility to work in a matrixed and geographically diverse business in a fast-paced changing environment\nAbility to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.\nStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner.\nStrong organizational, planning, and follow-up skills and ability to hold others accountable.\nAbility to travel approximately 10%, including the potential for international travel.\nPreferred:\nNice to have cardiovascular medical device, Software as a Medical Device (SaMD), and Medical Device Data System (MDDS) experience.\nFamiliarity with TIR45 and Agile Software Development methodologies.\nNice to have certifications in ASQ SQE, SixSigma Black belt, Agile software development, and/or other scrum processes.\nExperience using requirements, test management, and work tracking tools, such as Jama and Jira.\nOther:\nThis position may require up to 10% domestic travel.\nJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.\nFor more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]","company":"Johnson","rawCompany":"johnson","city":"Danvers","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-04-12T20:59:43.518Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"}],"industries":[{"code":"513210","title":"Software Publishers","slug":"software-publishers"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manager, Software Design Quality Engineering","description":"Johnson & Johnson is currently recruiting for Manager, Software Design Quality Engineering! This position will be located in Danvers, MA!\n\nAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\n\nPosition Summary:\nThe Software Design Quality Engineering Manager leads a team utilizing Software Design Quality Engineering, and Risk Management techniques and expertise to provide management and functional support for the entire software development life cycle (SDLC) of Abiomed’s software products. This position also supports company compliance with applicable federal, industry, and corporate procedures, guidelines, and regulations during the design, development, test, and installation of software products and the software aproducts for US and ROW.\n\nPrimary Duties and Responsibilities:\nLead Software Design Quality Engineering team in support of Abiomed’s Product Development and Software Development Life Cycle processes for various medical device projects. Including Software in Medical Device (SiMD), MDDS, CDS, IoT, Multi-function devices, and SaMD projects.\nAccountable for the Software Risk Management, Software Development Lifecycle, Design Control, and Change Control processes.\nRepresent the Software Design Quality Engineering function in Notified Body and Regulatory body audits/inspections\nDesign and implement process improvements for the Software Design Quality Engineering function, in areas such as design controls, change control, risk management, and software anomaly tracking.\nDefine and communicate overall objectives for the Software Design Quality team.\nManage long and short-term planning for the Software Design Quality Engineering team, including training, development, and goal setting.\nBuild and maintain strong interpersonal relationships within and outside of the business unit.\nSupport and ensure adherence to Abiomed’s product cybersecurity processes.\nEnsure robust processes are employed in new product development.\nProvide input and leadership for Quality policies, approaches, and standard practices.\nSupport maintaining alignment with US and International regulations and standards, as well as Abiomed quality systems.\nIdentify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), EU MDR, ISO 13485, ISO 14971, IEC 62304, etc.\n\nQualifications\nEducation:\nBachelor’s degree in sciences or engineering with minimum 8 years in quality desired with at least 2 years in a leadership role\nRequired:\nMust have software quality experience working with and on Software Safety Class C medical device products, FDA Class III or II medical devices\nExperience with Domestic and International regulatory requirements and working with regulating bodies.\nWorking knowledge and practical application of relevant requirements of 21 CFR Part 820, EU MDR, ISO and IEC standards\nStrong leadership skills with demonstrated ability to create momentum and deliver excellent results.\nAbility to work in a matrixed and geographically diverse business in a fast-paced changing environment\nAbility to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.\nStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner.\nStrong organizational, planning, and follow-up skills and ability to hold others accountable.\nAbility to travel approximately 10%, including the potential for international travel.\nPreferred:\nNice to have cardiovascular medical device, Software as a Medical Device (SaMD), and Medical Device Data System (MDDS) experience.\nFamiliarity with TIR45 and Agile Software Development methodologies.\nNice to have certifications in ASQ SQE, SixSigma Black belt, Agile software development, and/or other scrum processes.\nExperience using requirements, test management, and work tracking tools, such as Jama and Jira.\nOther:\nThis position may require up to 10% domestic travel.\nJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.\nFor more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]","datePosted":"2026-04-12T20:59:43.518Z","dateModified":"2026-04-12T20:59:43.518Z","hiringOrganization":{"@type":"Organization","name":"Johnson","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Danvers","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"4a644d5842e52a330e34cae9"},"url":"https://jobsearcher.com/jobs/4a644d5842e52a330e34cae9"}}