We anticipate the application window for this opening will close on - 11 Jul 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

Senior Software Quality Engineer

Careers that Change Lives

Transforming hypertension treatment, Renal denervation for hypertension!

This is a Software Design Assurance role focused on regulatory compliance, design control, and risk management for SaMD and digital health; not a traditional QA Software test execution position. Ideal for quality engineers passionate about driving innovation through systems and establishing process compliance.

Join Medtronic’s Coronary & Renal Denervation (CRDN) team, where we’re transforming hypertension treatment with cutting-edge digital health and energy-based medical technologies. Be part of a mission-driven organization committed to alleviating pain, restoring health, and extending life.

Our Symplicity Spyral™ Renal Denervation (RDN) System represents the future of hypertension therapy. Now, we're expanding into Digital Health with Software as a Medical Device (SaMD) and AI-powered solutions—and we want innovative minds to help lead the way.

Treatments We Offer:

Renal Denervation

Key Technologies

Symplicity Spyral™ Renal Denervation (RDN) System

Medtronic’s Coronary and Renal Denervation (CRDN) business is looking for a Senior Software Quality Engineer to be part of a high-performing team that is revolutionizing the design and development of energy based therapeutic medical devices to treat hypertension. In this role, you will leverage both your technical breadth and business acumen to support the newly approved Hypertension therapy software as medical device (SaMD) and participate in the design and development of next generation medical devices.

This position is in Mounds View, MN within the Coronary & Renal Denervation (CRDN) Operating Unit and requires on-site presence three days a week.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in Life:

As a Senior Software Quality Engineer – Digital Health, you’ll provide quality engineering leadership for web, mobile, and AWS-based cloud applications, including SaMD platforms. You will ensure compliance with global regulatory standards, manage risk and cybersecurity, and champion software quality throughout the development lifecycle.

You’ll collaborate closely with R&D, Regulatory Affairs, and Systems Engineering to deliver reliable, secure, and compliant digital health solutions.

In general, the following responsibilities apply for the role. This includes, but is not limited to the following:

• Software Design Assurance Leadership – Provide technical leadership in software quality engineering for Digital Health (DH) and Software as a Medical Device (SaMD) product within the Coronary and Renal Denervation (CRDN) business.
• Regulatory Compliance & Standards – Ensure compliance with global medical device regulations and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and applicable AI/ML regulations.
• Risk Management & Cybersecurity – Lead software risk management activities per ISO 14971 and IEC 81001-5-1, ensuring robust hazard analysis, risk controls, and cybersecurity measures for DH/SaMD solutions.
• Software Development Lifecycle (SDLC) Oversight – Provide quality oversight for software development, verification, validation, and release activities, ensuring adherence to Medtronic’s design control processes.
• AWS-Based Web & Mobile Application Assurance – Drive software design assurance activities for AWS-based cloud applications and mobile apps, ensuring compliance with software development best practices, cloud security, and regulatory requirements for SaMD.
• Design Control & Quality Engineering – Ensure rigorous software design control activities, including requirements review, design verification, validation planning, and defect tracking, to enhance software quality and reliability.
• Digital Health & AI/ML Assurance – Support assurance activities for AI/ML-enabled medical software, ensuring proper data integrity, algorithm validation, and continuous learning risk controls.
• Process Improvement & QMS Enhancements – Contribute to the advancement of Medtronic’s Software Quality Management System (QMS), focusing on process efficiency, compliance, and best pr