Software Quality Director - CRDN

We anticipate the application window for this opening will close on - 1 Apr 2026At 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**Software Quality Director Careers that Change Lives Transforming Patient Management with Smart Technology! At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. Medtronic Coronary & Renal Denervation (CRDN) Operating Unit develops the next generation medical technologies that alleviate pain, restore health, and extend life for millions of patients across the world. Treatments We Offer: Renal Denervation Key Technologies Symplicity Spyral(TM) Renal Denervation (RDN) System Why This Role Stands Out: • Lead Innovation: Be at the forefront of digital transformation, influencing software quality, design assurance, and risk management for life-changing therapies. • Collaborate & Grow: Work side-by-side with talented Agile Scrum teams in a dynamic environment that values continuous improvement and creative problem-solving. • Impact the Future: Play a critical role in ensuring our software—from Capital SiMD and SaMD to non-medical device solutions—is safe, effective, and compliant. A Culture Where You Belong: 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. On-site Collaboration for Excellence: 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**:The Software Quality Director will lead our software quality organization within CRDN supporting both current products in the markets, ensuring ongoing reliability, performance and customer satisfaction as well as new product development and release initiatives. This role is accountable for managing and developing a high-performing quality Engineering team, defining the long-term quality strategy, and ensuring the delivery of reliable, high-quality software across our product portfolio.The Software Quality Director will balance strategic vision with operational excellence- driving quality initiatives across the organization while overseeing day-to-day management, mentoring, and cross-functional collaboration.In general, the following responsibilities apply for the **Software Quality Director** role. This includes, but is not limited to the following:* Develop and execute a comprehensive software quality strategy supporting growth, scalability, and evolving products.* Collaborate with global partners in quality, regulatory, and R&D to align quality and digital transformation goals.* Anticipate and adapt the quality function for emerging technologies and future needs.* Lead, mentor, and grow a high-performing, diverse team focused on software design assurance and risk management.* Oversee all aspects of software design assurance and risk management for all software products (Capital Equipment with Embedded Software, Software as Medical Device (SaMD), Non-Medical Device Software), to ensure regulatory compliance and support audits and submissions (FDA, ISO 13485, IEC 62304, IEC 82304, ISO 14971, etc.).* Champion continuous improvement and best practices in software engineering, verification, validation, and documentation.**MUST HAVE - MINIMUM REQUIREMENTS:****TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME*** Bachelor’s degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical discipline and a minimum of 10 years of Software Development experience OR a Master’s degree with a minimum of 7 years of Software Development experience, along with 7 years of managerial experience**Nice to Have*** 7+ years of experience in software quality assurance or software development in the medical device industry.* 5+ years of experience leading teams in Agile/Scrum environments.* In-depth knowledge of relevant standards and regulations (IEC 62304, ISO 13485, FDA QSR, ISO 14971).* Demonstrated experience with software engineering and product quality for Capital SiMD, SaMD, and Non-Medical Device Software.* Demonstrated experience with Agile/Scrum methodologies, digital transformation initiatives, and continuous improvement frameworks (Lean, Kaizen, etc.).* Scaled-Agile Principles awareness and execution experience* Software reliability best practices* Product Security Risk Management* AI/ML based software release experience**About Medtronic** Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)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.**Physical Job Requirements**The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.**U.S. Work Authorization & Sponsorship**At Medtronic, we are committed to fostering an environment where employees can thrive
#J-18808-Ljbffr