Sr. Quality Program Manager (Cardiac Electrophysiology) jobs in United States
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Medtronic · 5 hours ago

Sr. Quality Program Manager (Cardiac Electrophysiology)

Medtronic is a global leader in healthcare technology, committed to innovation and patient care. The Senior Quality Program Manager will serve as a Quality Core Team Member for cardiac electrophysiology programs, ensuring compliance and quality throughout the product lifecycle while collaborating with cross-functional teams.

Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
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H1B Sponsor Likelynote

Responsibilities

Acts as the Quality Core Team Member (QCTM) and program‑level Quality lead for assigned product development programs, with accountability for quality strategy, execution, and outcomes across the full product lifecycle
Plans, directs, and oversees all Quality aspects of design and development, ensuring compliance with Medtronic policies, global regulatory requirements, and applicable quality system regulations
Leads and integrates Quality program planning, including design control strategy, design verification planning, risk management planning, design transfer readiness, and post‑market quality considerations
Provides Quality leadership for design verification and validation activities, including review and approval of test strategies, protocols, methods, execution readiness, and test results
Ensures robust test method development, qualification, and validation, partnering with engineering, manufacturing, and suppliers to establish reliable, reproducible, and compliant methods
Owns and drives product and process risk management activities, including hazard analysis, FMEAs, and risk/benefit assessments, ensuring alignment with system architecture, clinical intent, and real‑world use
Leads Quality oversight for design transfer, collaborating with manufacturing, supplier quality, operations, and regulatory partners to ensure product and process readiness for commercialization
Guides cross‑functional teams through phase gate reviews, design reviews, and key quality decision points, providing clear recommendations and risk‑based decision support
Monitors and ensures the integrity of design history file (DHF) documentation, traceability, and configuration management throughout the development lifecycle
Coordinates Quality activities with external suppliers, test labs, and consultants, ensuring timely delivery, compliance, and risk mitigation
Identifies gaps, risks, and improvement opportunities within Quality processes and program execution; drives corrective actions and continuous improvement initiatives
Is a mentor, leader or direct manager to earlier career QCTMs
Other duties may be assigned

Qualification

Quality program leadershipDesign controlsRisk managementDesign verificationClass III medical devicesQuality systems knowledgeCross-functional team leadershipContinuous improvementMentoring

Required

Bachelor's degree and a minimum of 7 years of relevant experience
OR an advanced degree with a minimum of 5 years of relevant experience

Preferred

Experience working with Class III medical devices
Broad knowledge of Quality systems and product development, with mastery in at least one technical or professional discipline and working knowledge across adjacent functions
Proven experience leading cross‑functional, matrixed teams on complex product development programs
Strong understanding of design controls, design verification and validation, risk management, test methods, and design transfer

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

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Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.

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 Company
Total Funding
$18.16B
Key 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

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Geoffrey Martha
CEO and Chairman Of The Board Of Directors
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Linnea Burman
SVP & President, Neurovascular
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Company data provided by crunchbase