Software Quality Engineering Program Manager – Quality Core Team Member

Role Overview

• 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, DevOps, 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, DevOps, 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 live cases 2–3 times per year to enhance workflow and product knowledge
• Coordinates Software Quality activities as appropriate with external suppliers, test vendors, and consultants, ensuring timely delivery, compliance, cybersecurity posture, and risk mitigation
• Identifies gaps, risks, and improvement opportunities in software quality processes, SDLC execution, test automation, defect prevention, and post market feedback loops; drives corrective actions and continuous improvement initiatives
• Serves as a mentor, technical leader, or potential direct manager to earlier career Software Quality engineers or Software QCTMs.

Requirements

• Bachelor's degree and a minimum of 5 years of relevant experience OR Advanced degree with a minimum of 3 years of relevant experience
• Ability to effectively read, interpret, and understand existing software code
• Excellent written and oral communication skills
• 5+ years of medical device industry experience
• 5+ years of industry experience in software development
• Strong knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support
• Experience with cardiac and electrophysiology medical specialties
• Advanced degree in a relevant field
• Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar)

Tech Stack

• Cyber Security
• SDLC

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)