Medtronic Coronary & Renal Denervation (CRDN) Operating Unit is seeking a Quality Software Director to support their newly approved therapy software and shape the future of next-generation devices, ensuring the safety, effectiveness, and compliance of their software products.
Requirements
- 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
Responsibilities
- Develop and execute a comprehensive software quality strategy supporting growth, scalability, and evolving products.
- 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.
- 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.
- Collaborate with global partners in quality, regulatory, and R&D to align quality and digital transformation goals.
Other
- 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
- This position is in Mounds View, MN.
- This role will require less than 10% of travel
- On-site Collaboration for Excellence: This position is in Mounds View, MN. ... 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.
