Sr. Software Quality Engineer

Medtronic•Mounds View, MN

15h•Onsite

About The Position

At Medtronic, you can begin a life-long career of exploration and innovation, helping champion healthcare access and equity for all. You will lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Medtronic brings bold ideas forward with speed and decisiveness to put patients first. In-person exchanges are invaluable, requiring a minimum of 4 days a week onsite to foster professional growth and cross-functional collaboration. As a Senior Software Quality Engineer, you will transform lives through advanced medical technology, working alongside engineers and cross-functional partners to drive quality for the design, development, and maintenance of software for Affera cardiac electrophysiology systems. This role offers the opportunity to impact global healthcare by blending technical expertise with a passion for quality, compliance, and improving patient outcomes as Affera's usage grows worldwide.

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

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.