As a Senior Quality Program Manager on Medtronic’s Quality Core Team, you will lead quality initiatives for complex cardiac electrophysiology programs, collaborating with R&D, Systems Engineering, Manufacturing, Regulatory, Clinical, and Operations teams. Your daily responsibilities include developing and executing quality strategies, overseeing design verification and validation activities, ensuring robust test method development, and managing risk assessments to ensure regulatory compliance and patient safety. You will also guide cross-functional teams through phase gate reviews and maintain the integrity of design history files. The role requires expertise in Quality systems, product development, and a deep understanding of design controls, risk management, and design transfer. Ideal candidates have experience with Class III medical devices and leading complex product development programs. This position is crucial for ensuring high-quality product delivery as Medtronic’s Affera technology scales globally.
Skills
Quality systems
Design controls
Risk management
Test methods
Design transfer
Cross-functional team leadership
Regulatory compliance
Medical devices
Configuration management
Phase gate reviews
DHF documentation
Supplier quality
Manufacturing readiness
Continuous improvement
Program planning
What you'll do
Acts as Quality Core Team Member and program-level Quality lead for product development, ensuring compliance with policies and regulations.
Leads Quality program planning, including design control strategy, risk management, and post-market quality considerations.
Provides leadership for design verification and validation activities, reviewing test strategies and results for approval.
Owns product and process risk management, conducting hazard analysis and FMEAs to ensure alignment with clinical intent.
Oversees design transfer readiness, collaborating with manufacturing and regulatory partners for commercialization preparation.
Coordinates Quality activities with external suppliers and consultants to ensure timely delivery and compliance.
Identifies gaps and improvement opportunities within Quality processes, driving corrective actions and continuous improvements.
What we're looking for
At least 5 years of experience in medical device quality management or an advanced degree.
Experience with Class III medical devices and complex product development programs.
Mastery in Quality systems, design controls, risk management, and test methods.
Proven leadership in cross-functional teams on technical projects.
Expertise in program planning, verification/validation activities, and design transfer.
Strong understanding of regulatory compliance and patient safety standards.
Mentorship or direct management experience with early-career quality professionals.
Market check
Salary context
This
$171,200–$256,800
range sits above
74%
of similar postings on FindRole.
Peer median band
$139,950–$220,500
Median floor and ceiling across peers.
Typical midpoint (25–75%)
$149,443–$214,900
Middle half of comparable postings.
Based on 238 comparable postings.*
* 240 is the maximum number of comparable postings sampled.
Employer
About Medtronic
Medtronic plc is the world's largest medical technology company by revenue, specializing in device-based therapies for over 70 health conditions.
Medtronic currently has
24 open roles
on FindRole.
Listed pay typically runs
$135,200–$198,000
across 24 roles with salary data.
Remote (Usa-Co Lafayette Bldg 1, US)18 days ago
$138,400–$207,600
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