Sr. Software Quality Engineer

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.

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’ll work 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 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.

• 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.

10%

• 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

• 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 (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.
• Experien…