Software Quality Engineering Program Manager; Quality Core Team Member

We anticipate the application window for this opening will close on - 16 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.

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’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross‑functional collaboration as we work together to engineer the extraordinary.

Open to our Newton, MA or Mounds View, MN offices.

In this dynamic role, you’ll work alongside a team of engineers and cross‑functional partners to support design, development, and maintenance of software for Affera cardiac electrophysiology systems. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide.

• Acts as the Software Quality Core Team Member (QCTM) and program level Software Quality lead for assigned software and software‑enabled product development programs, with accountability for software quality strategy, execution, and outcomes across the full product lifecycle.
• Plans, directs, and oversees all Software Quality aspects of design and development for assigned products, ensuring compliance with Medtronic policies, global regulatory requirements, and applicable quality system and software lifecycle regulations (e.g., IEC 62304, ISO 14971, FDA software guidance).
• Leads and integrates Software Quality program planning, including software lifecycle strategy, software design control approach, verification and validation strategy, cybersecurity and data integrity considerations, risk management planning, release readiness, and post‑market software quality planning. Coordinate quality team members and ensure accountability for completing functional work within program deadlines.
• Provides Software Quality leadership for software verification and validation activities, including review and approval of test strategies, test levels (unit, integration, system, and acceptance), automated testing approaches, protocols, execution readiness, defect management, and test results.
• Ensures robust software test method development and qualification, partnering with software engineering, systems engineering, Dev Ops, and test teams to establish scalable, repeatable, traceable, and compliant testing frameworks and environments.
• Owns and drives software and system risk management activities, including software hazard analysis, software FMEAs, cybersecurity risk assessments, and risk/benefit evaluations, ensuring alignment with system architecture, clinical intent, user workflows, and real‑world operating environments.
• Leads Software Quality oversight for software release and deployment readiness, collaborating with development, Dev Ops, IT, manufacturing systems, supplier quality, and regulatory partners to ensure controlled builds, configuration management, validation status, and commercialization readiness.
• Guides cross‑functional teams through software phase gate reviews, design reviews, release reviews, and key quality decision points, providing clear, risk‑based recommendations and quality leadership.
• Monitors and ensures the integrity of software documentation and records, including software development files, traceability matrices, requirements to test linkage, configuration management, and change control throughout the software lifecycle.
• Drive and analyze software quality metrics for assigned programs, ensuring continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.
• Develop strong expertise in assigned products, including hands‑on time in the engineering lab and participation in product training as assigned. Attend…