Medtronic
We anticipate the application window for this opening will close on - 28 Oct 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.
A Day in the Life
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. *This can sit out of our Independence, OH, Mounds View, MN, or Newton, MA office* Join Medtronic as a
Software Quality Engineer II
and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and maintenance of operating systems and manufacturing/service tooling software releases for Affera cardiac electrophysiology systems. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide. Primary 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 operating system and service/manufacturing tooling software releases across the Affera portfolio. Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.
Review and approve various Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling. Ensure all 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 and process 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 levels of product reliability.
Provide software quality support for post-market activities and analysis, including work supporting issue assessments, health risk assessments, and CAPAs.
Recommend design or test methods to achieve appropriate levels of 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 business needs permit, periodically visit manufacturing and servicing facilities to aid in understanding of quality processes related to software loading and tooling.
Regularly participate in virtual electrophysiology patient case learning opportunities.
Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
Travel
Travel Requirements
Required Qualifications
Bachelor's degree and a minimum of 2 years of relevant experience
OR Master’s degree with a minimum of 0 years of relevant experience
Preferred Qualifications
Ability to demonstrate basic competency in coding, and effectively read, interpret, and understand existing software code.
Excellent written and oral communication skills.
1+ years of industry experience working with a software development team.
Experience creating risk analysis documentation such as FMEAs and FTAs.
Experience using or working with products built on Python, Linux, Docker, Windows, AWS, REST APIs, React, and/or Flutter/Dart.
Knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.
Advanced degree in a relevant field.
Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar).
Note:
This description reflects responsibilities and qualifications for the role and does not create a contract of employment. Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $80,800.00 - $121,200.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, and Capital Accumulation Plan. Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. in any position which will involve performing at least two hours of work on average each week within Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. *This can sit out of our Independence, OH, Mounds View, MN, or Newton, MA office* Join Medtronic as a
Software Quality Engineer II
and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and maintenance of operating systems and manufacturing/service tooling software releases for Affera cardiac electrophysiology systems. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide. Primary 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 operating system and service/manufacturing tooling software releases across the Affera portfolio. Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.
Review and approve various Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling. Ensure all 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 and process 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 levels of product reliability.
Provide software quality support for post-market activities and analysis, including work supporting issue assessments, health risk assessments, and CAPAs.
Recommend design or test methods to achieve appropriate levels of 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 business needs permit, periodically visit manufacturing and servicing facilities to aid in understanding of quality processes related to software loading and tooling.
Regularly participate in virtual electrophysiology patient case learning opportunities.
Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
Travel
Travel Requirements
Required Qualifications
Bachelor's degree and a minimum of 2 years of relevant experience
OR Master’s degree with a minimum of 0 years of relevant experience
Preferred Qualifications
Ability to demonstrate basic competency in coding, and effectively read, interpret, and understand existing software code.
Excellent written and oral communication skills.
1+ years of industry experience working with a software development team.
Experience creating risk analysis documentation such as FMEAs and FTAs.
Experience using or working with products built on Python, Linux, Docker, Windows, AWS, REST APIs, React, and/or Flutter/Dart.
Knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.
Advanced degree in a relevant field.
Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar).
Note:
This description reflects responsibilities and qualifications for the role and does not create a contract of employment. Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $80,800.00 - $121,200.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, and Capital Accumulation Plan. Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. in any position which will involve performing at least two hours of work on average each week within Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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