Software Quality Director - CRDN

Medtronic•Mounds View, MN

4d•$218,400 - $327,600•Onsite

About The Position

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™ Renal Denervation (RDN) System Are you ready to make a real impact? Medtronic’s CRDN business is seeking a Quality Software Director to join a high-performing team that’s pioneering the design and development of energy-based therapeutic medical devices for hypertension treatment. In this role, you’ll blend your technical expertise and business acumen to support our newly approved therapy software and help shape the future of next-generation devices. 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.

Requirements

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 Haves

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

Responsibilities

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.