Sr. Software Quality Engineer (Reliability/Compliance)

Medtronic; Mounds View (MN); On-site; USD 103,000 - 155,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Tuition assistance

Job summary

Medtronic is seeking a Senior Software Quality Engineer to ensure regulatory compliance and reliability across cardiac electrophysiology software for Affera systems. You will collaborate with R&D, regulatory, and clinical teams to uphold software quality from design through post-market support.

In this in-person role, you will review DHF documents, participate in software risk analyses, and contribute to quality metrics while supporting post-market activities. Travel is <10% as needed.

Qualifications

• Bachelor’s degree and a minimum of 4 years of relevant experience
• Master’s degree with a minimum of 2 years of relevant experience
• PhD with 0 years relevant experience

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 member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures.
• 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.
• Develop and review documentation for traceability, testability, and compliance according to SOPs.
• Develop expertise in assigned products and projects through hands-on time in the engineering lab and product training.
• Participate in software risk analysis and defect assessments.
• Contribute to tracking software quality metrics and supporting continuous improvement of quality outcomes.
• Provide software quality support for post-market activities and CAPA analyses.

Skills

Python

Qt

Docker

Linux

Cybersecurity

Regulated industry

Software quality

Education

Bachelor's degree

Master's degree

PhD

Tools

FMEA

FTA

Job description

We anticipate the application window for this opening will close on - 8 Sep 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

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.

Join Medtronic as a Senior Software Quality Engineer and be at the forefront of transforming lives through advanced medical technology! In this dynamic role,you’llwork alongside a team of engineers and cross-functional partners to drive quality for design, development, and maintenance of software for Affera cardiac electrophysiology systems.By blending technicalexpertisewith a passion for quality, compliance, and improving patient outcomes,you’llhave the opportunity toimpactglobal 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 asmemberof the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures.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.

• Developexpertisein 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 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 achieveappropriate levelsof 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 reliabilityobjectivesfor 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 and product knowledge.Regularlyparticipatein virtuallivecase learning opportunities.

• Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.

• Travel Requirement: <10%

Required Qualifications

• Bachelor’s degree anda minimum of4years of relevant experience

• ORMaster’sdegree witha minimum of2years of relevant experience

• OR PhD with 0 years relevant experience
  

Preferred Qualifications

• At least 1 year of experience supporting product development.

• Though this is not a coding role, the ability to perform simple coding tasks and effectively read, interpret, and understand existing software codetocollaborate and execute necessary work with software engineers is needed

• Excellent written and oral communication skills.

• 2+ years of medical device or other regulated industry (such as defense or aerospace) experience.

• 2+ 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, Qt, Docker, and Linux.

• Strong knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.

• Experience with cardiac and electrophysiology medical specialties.

• Advanced degree in a relevant field.

• Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar).

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration 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):$103,200.00 - $154,800.00

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 ratecomplies withfederal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits informationpertainssolely to candidates hired within the United States (local market compensation and benefits will apply for others).

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, andSimple 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 (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

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. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here 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.