Medtronic
Overview
Join to apply for the
Sr. Software Quality Engineer
role at
Medtronic . We anticipate the application window for this opening will close on 3 Nov 2025. At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Join Medtronic as a
Senior
Software Quality Engineer
and be at the forefront of transforming lives through advanced medical technology. In this role you’ll work with a team of engineers and cross-functional partners to drive quality for software design, development, and maintenance for Affera cardiac electrophysiology systems. In-person exchanges are valuable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to professional growth and cross-functional collaboration to engineer the extraordinary. Responsibilities
Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. Serve as a member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures. Collaborate with other quality team members to complete assigned functional work within program deadlines. Review and approve Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling. Ensure documentation meets reliability standards and follows QMS processes. Develop and review documentation for traceability, testability, and compliance according to standard operating procedures. Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned. Participate in software risk analysis and defect assessments as assigned. Contribute to tracking software quality metrics for assigned programs, supporting continuous monitoring and improvement of quality outcomes to achieve required reliability levels. Provide software quality support for post-market activities and analysis, including issue assessments, health risk assessments, and CAPAs. Recommend design or test methods to achieve appropriate levels of product reliability and security; propose changes to design or testing as necessary to improve software and/or process reliability. Contribute to reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs. Review and support strategies for product security testing as assigned. As available, attend a live EP case at least once per year to enhance workflow; regularly participate in virtual live case learning opportunities. Collaborate with cross-functional teams (R&D, regulatory affairs, clinical teams) to ensure alignment on quality and compliance requirements. Qualifications
Required Qualifications
Bachelor's degree and a minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience Preferred Qualifications
At least 1 year of experience supporting product development Ability to perform simple coding tasks and effectively read, interpret, and understand existing software code Excellent written and oral communication skills 2+ years of medical device or other regulated industry experience (e.g., defense or aerospace) 2+ years of experience working with a software development team Experience creating risk analysis documentation such as FMEAs and FTAs Experience with Python, Qt, Docker, and Linux Strong knowledge of cybersecurity and the software lifecycle in regulated environments Experience with cardiac and electrophysiology medical specialties Advanced degree in a relevant field (preferred) Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ or similar) (preferred) Travel
Travel may be required as part of the role. Physical Job Requirements
The statements are intended to describe the general nature and level of work. They are not an exhaustive list of all responsibilities and skills. Reasonable accommodations may be made for qualified individuals with disabilities. Office roles may require regular mobility and computer use. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. We recognize contributions and provide a wide range of benefits, resources, and compensation plans to support employees at every career and life stage. Salary ranges for U.S. locations (USD): $102,400.00 - $153,600.00. This position is eligible for a short-term incentive through the Medtronic Incentive Plan (MIP). Base salary and benefits vary by experience, certification/education, market conditions, and location. Benefits details pertain to candidates hired within the United States; local market packages apply elsewhere. Regular employees receive health, dental, vision, life insurance, disability coverage, retirement plans, paid time off, and other programs described in the benefits plan. It is Medtronic’s policy to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, gender, sexual orientation, gender identity or expression, genetic information, marital status, veteran status, or any other characteristic protected by law. Reasonable accommodations are available for qualified individuals with disabilities. About Medtronic: We lead global healthcare technology and are committed to diversity, equity, and inclusion. Our mission is to alleviate pain, restore health, and extend life. For additional details, refer to the Medtronic benefits and compensation plans page.
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Join to apply for the
Sr. Software Quality Engineer
role at
Medtronic . We anticipate the application window for this opening will close on 3 Nov 2025. At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Join Medtronic as a
Senior
Software Quality Engineer
and be at the forefront of transforming lives through advanced medical technology. In this role you’ll work with a team of engineers and cross-functional partners to drive quality for software design, development, and maintenance for Affera cardiac electrophysiology systems. In-person exchanges are valuable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to professional growth and cross-functional collaboration to engineer the extraordinary. Responsibilities
Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. Serve as a member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures. Collaborate with other quality team members to complete assigned functional work within program deadlines. Review and approve Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling. Ensure documentation meets reliability standards and follows QMS processes. Develop and review documentation for traceability, testability, and compliance according to standard operating procedures. Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned. Participate in software risk analysis and defect assessments as assigned. Contribute to tracking software quality metrics for assigned programs, supporting continuous monitoring and improvement of quality outcomes to achieve required reliability levels. Provide software quality support for post-market activities and analysis, including issue assessments, health risk assessments, and CAPAs. Recommend design or test methods to achieve appropriate levels of product reliability and security; propose changes to design or testing as necessary to improve software and/or process reliability. Contribute to reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs. Review and support strategies for product security testing as assigned. As available, attend a live EP case at least once per year to enhance workflow; regularly participate in virtual live case learning opportunities. Collaborate with cross-functional teams (R&D, regulatory affairs, clinical teams) to ensure alignment on quality and compliance requirements. Qualifications
Required Qualifications
Bachelor's degree and a minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience Preferred Qualifications
At least 1 year of experience supporting product development Ability to perform simple coding tasks and effectively read, interpret, and understand existing software code Excellent written and oral communication skills 2+ years of medical device or other regulated industry experience (e.g., defense or aerospace) 2+ years of experience working with a software development team Experience creating risk analysis documentation such as FMEAs and FTAs Experience with Python, Qt, Docker, and Linux Strong knowledge of cybersecurity and the software lifecycle in regulated environments Experience with cardiac and electrophysiology medical specialties Advanced degree in a relevant field (preferred) Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ or similar) (preferred) Travel
Travel may be required as part of the role. Physical Job Requirements
The statements are intended to describe the general nature and level of work. They are not an exhaustive list of all responsibilities and skills. Reasonable accommodations may be made for qualified individuals with disabilities. Office roles may require regular mobility and computer use. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. We recognize contributions and provide a wide range of benefits, resources, and compensation plans to support employees at every career and life stage. Salary ranges for U.S. locations (USD): $102,400.00 - $153,600.00. This position is eligible for a short-term incentive through the Medtronic Incentive Plan (MIP). Base salary and benefits vary by experience, certification/education, market conditions, and location. Benefits details pertain to candidates hired within the United States; local market packages apply elsewhere. Regular employees receive health, dental, vision, life insurance, disability coverage, retirement plans, paid time off, and other programs described in the benefits plan. It is Medtronic’s policy to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, gender, sexual orientation, gender identity or expression, genetic information, marital status, veteran status, or any other characteristic protected by law. Reasonable accommodations are available for qualified individuals with disabilities. About Medtronic: We lead global healthcare technology and are committed to diversity, equity, and inclusion. Our mission is to alleviate pain, restore health, and extend life. For additional details, refer to the Medtronic benefits and compensation plans page.
#J-18808-Ljbffr