Medtronic · 2 months ago
Software Reliability Engineering Program Manager (Quality Core Team Member)
Newton, Massachusetts, United States of America
Full-time
Onsite
Senior Level
$150K/yr - $226K/yr
5+ years expMedtronic is a leader in global healthcare technology, dedicated to solving challenging health problems. They are seeking a Software Reliability Engineering Program Manager to support the design, development, and maintenance of software for cardiac electrophysiology systems, ensuring quality and compliance with regulatory standards.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485
Serve as the Quality Core Team Member for Affera software releases. Coordinate quality team members and ensure accountability for completing functional work within program deadlines
Review and approve Design History File and other documentation related to software and security, including plans, change assessments, requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling. Ensure all documentation meets reliability standards and follows QMS processes
Develop and review documentation for traceability, testability, and compliance according to standard operating procedures
Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned
Participate in software risk analysis and defect assessments
Influence and analyze software quality metrics for assigned programs, ensuring continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability
Provide software quality support for post-market activities and analysis, including issue assessments, health risk assessments, and CAPAs. Ensure ongoing compliance and reliability of released software products
Recommend design or test methods to achieve appropriate levels of product reliability and security. Propose changes to design or testing as necessary to improve software and/or process reliability
Analyze preliminary plans and develop reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs
Review and support strategies for product security testing
Obtain and maintain hospital credentialing to attend live EP cases 2–3 times per year to enhance workflow and product knowledge
Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements
Travel Requirement: <10%
Qualification
Required
Bachelor's degree and a minimum of 5 years of relevant experience
OR Advanced degree with a minimum of 3 years of relevant experience
Preferred
Minimum of 5 years of experience across any of the following disciplines: software development or testing, quality or reliability engineering, or field/research experience in a cardiac electrophysiology lab
At least 2 years of product development experience within the medical device or another regulated industry
Ability to perform simple coding tasks and effectively read, interpret, and understand existing software code
Excellent written and oral communication skills
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)
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
2026-01-09
Beyond Bylines
2026-01-09
2026-01-08
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