Senior Engineering Program Manager - Quality Core Team Member, Brooklyn Park, MN or Dexter, MI

We anticipate the application window for this opening will close on - 4 Mar 2026.

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.

Join Medtronic as a Sr. Engineering Program Manager – Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross‑functional partners to support design and development of cardiac surgery products. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare.

Join a diverse team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. It’s no accident ‑ we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology.

Cardiac Surgery represents end‑stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio.

• Surgical heart valves
• Cardiac OR solutions (e.g., blood management, cannulae)
• Extracorporeal life support
• Coronary artery bypass grafting (CABG) solutions

• Support quality and reliability efforts for Cardiac Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, and ISO 13485.
• Coordinate quality team members and ensure accountability for completing functional work within program deadlines from design concept to design transfer to early commercialization.
• Develop quality functional strategies, plans, and schedules to meet project goals and manage risks.
• Represent the Voice of Quality across all global quality disciplines, ensuring quality requests are defined, implemented, and met throughout the project.
• Collaborate with cross‑functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
• Maintain alignment and manage execution across global quality disciplines, communicating key program information to ensure core team and leadership engagement.
• Plan and manage program resource allocation and budget.
• Identify quality program risks and implement risk burn‑down strategies.
• Ensure an effective transfer to global post‑market quality functions.

• Review and approve Design History File and related documentation, including plans, requirements, design, development, test protocols, test reports, verification, and validation.
• Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
• Build expertise in assigned products and projects, including hands‑on time in the engineering lab and participation in product training.
• Collaborate with R&D, systems engineering, and cross‑functional teams to develop, qualify, and implement robust, repeatable, and compliant test method validations that ensure traceability and reliability of results.
• Proactively drive and champion strategic quality, reliability, and safety improvements through the risk management process and DRM initiatives.
• Facilitate the development of the product risk management file, ensuring process compliance with risk management procedures.
• Support hardware and software quality and reliability efforts for Cardiac Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.

• Enhance product development and program management processes to improve compliance.
• Act as an independent quality reviewer for Cardiac Surgery product development programs, guiding teams to robust and compliant quality strategies, documentation, and…