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

Principal Software Quality Engineer

Careers that Change Lives

Note: This is a Software Safety and Design Assurance role focused on patient risk management, regulatory compliance, design control oversight, for SaMD and digital health; not a traditional QA Software test execution position. Ideal for Software 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 Principal Software Safety / Design Assurance 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 platform software as medical device (SaMD) and participate in the design and development of next generation medical devices.

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.

This position is in Mounds View, MN. within the Coronary & Renal Denervation (CRDN) operating unit. 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 are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

A Day in the Life:

As a Principal Software Safety / Design Assurance Engineer – Digital Health (SaMD), you’ll provide quality engineering leadership for web, mobile, and digital health applications, including SaMD platforms. You will ensure compliance with global regulatory standards, manage safety risk and cybersecurity, and champion software design assurance activities throughout the development lifecycle.

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

As a Principal Software Safety / Design Assurance Engineer – Digital Health (SaMD), you will play a key role in ensuring safe, compliant, and high-quality software for next-generation medical devices.

• Risk Management & Cybersecurity
  • Lead software risk management per ISO 14971 and IEC 81001-5-1
  • Drive hazard analysis, risk controls, and cybersecurity assurance for Digital Health / SaMD solutions

• Software Design Assurance Leadership
  • Provide technical leadership in software quality engineering for Digital Health and SaMD products in the CRDN business
  • Partner with R&D to ensure safety and compliance throughout the software development lifecycle

• Regulatory / Quality System Compliance & Standards
  • Ensure alignment with FDA 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and emerging AI/ML regulations
  • Translate complex standards into practical guidance for engineering teams

• SDLC Quality Oversight
  • Oversee software development, verification, validation, and release activities
  • Ensure adherence to Medtronic design controls and global quality expectations

• Digital Health & AI/ML Assurance
  • Support quality assurance of AI/ML-enabled software, focusing on data integrity, algorithm validation, and continuous learning r