Sr. Software Quality Engineer

Medtronic•Mounds View, MN

22h•Hybrid

About The Position

At Medtronic, you can embark on a lifelong career of exploration and innovation, contributing to healthcare access and equity globally. The company fosters a culture of professional growth and cross-functional collaboration, requiring a minimum of 4 days a week onsite. As a Senior Software Quality Engineer, you will be instrumental in transforming lives through advanced medical technology, working with a team of engineers and cross-functional partners to ensure quality in the design, development, and maintenance of software for Affera cardiac electrophysiology systems. This role offers the opportunity to impact global healthcare as the usage of Affera systems expands worldwide. Medtronic leads global healthcare technology, addressing challenging health problems with a mission to alleviate pain, restore health, and extend life. The company comprises over 95,000 passionate individuals, engineers at heart, who experiment, create, build, improve, and solve to generate real solutions for real people. Medtronic is committed to diversity, equity, and inclusion, striving to build a better future, foster career growth, and connect employees to a dynamic and inclusive culture of lifelong learning. The company emphasizes putting people first, developing life-transforming technologies, achieving better outcomes for the world, and driving insight-driven care through fresh viewpoints and cutting-edge technology.

Requirements

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
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.

Nice To Haves

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 code to collaborate 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).

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.
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 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 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 and product knowledge.
Regularly participate in virtual live case learning opportunities.
Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.

Benefits

Competitive Salary and flexible Benefits Package
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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Paid sick time (for temporary employees, as required under applicable state law)