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Heartflow, a pioneering medical technology company focused on advancing coronary artery disease diagnosis and management, is seeking a Senior Manager of Device Quality Engineering. This role involves leading a high-performing team to ensure software quality and regulatory compliance for AI-driven healthcare solutions.
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Job Summary
Heartflow is a publicly traded medical technology company advancing the diagnosis of coronary artery disease using AI-driven non-invasive cardiac tests.
The Senior Manager will lead the global strategy for software quality and design excellence while bridging rapid Agile development with rigorous medical device regulations.
This role requires managing resource allocation to ensure predictable, complete, and high-quality releases for digital health solutions used by over 500,000 patients worldwide.
Matching Summary
Match Score: 75
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Heartflow, a pioneering medical technology company focused on advancing coronary artery disease diagnosis and management, is seeking a Senior Manager of Device Quality Engineering. This role involves leading a high-performing team to ensure software quality and regulatory compliance for AI-driven healthcare solutions.
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Salary
Base: $195,000 - $250,000; Bonus/Equity: Included; Benefits: Not specified
Skills & Requirements
Must-have
12+ years medical device quality experience
IEC 62304 ISO 14971 regulatory standards
Software Verification and Validation leadership
Design History File lifecycle management
FDA Notified Body audit representation
Nice-to-have
Mentoring next generation quality leaders
Agile best practices in regulated environments
Cybersecurity by design implementation
AI/ML validation framework expertise
Cross-functional executive influence
Key Requirements
Bachelor's degree in Software Engineering or related field
Master's degree or MBA strongly preferred
3-5 years formal management or leadership experience
ASQ CMQ/OE, CSQE, or Six Sigma Black Belt certification preferred