Irhythmtech
Vice President, Product Design Quality
Remote - US · Exec
Sponsorship not specified$266k-$346kDetected 30 days ago
AlgorithmsData AnalysisProduct ManagementPatient CareFDA RegulatoryMedical DevicesLeadershipCommunication
About the role
- The Vice President, Product Design Quality is a senior quality leadership role reporting directly to the SVP, Quality & Regulatory Affairs.
- This leader is responsible for establishing and driving a world-class Design Quality organization across hardware, software (SaMD), and risk management functions.
- The VP will play a critical role in regulatory remediation efforts, including leading responses to FDA warning letters, hosting regulatory inspections, and transforming design control and risk management processes into a sustainable, inspection-ready state.
Responsibilities
- Lead and scale the Design Quality organization, including hardware, software (SaMD), and risk management teams.
- Build a high-performing organization with strong talent development, succession planning, and capability building.
- Establish Design Quality as a strategic business partner to R&D, Clinical, Regulatory, and Operations.
- Partner closely with R&D leadership to ensure quality is embedded early and effectively in development programs.
- Partner with R&D, Clinical, Operations, Manufacturing, and Commercial, to ensure alignment and compliance.
- Design Quality & Product Lifecycle Management
- Ensure design controls, clinical evaluation, and risk management activities meet regulatory requirements (ISO 13485, FDA QSMR/ 21 CFR part 820, EU MDR, ISO 14971, SaMD and cybersecurity regulations
- Own and continuously improve Design Control, Design Transfer, and Risk Management processes across hardware and software products.
- Drive integration of quality into agile and AI/algorithm development environments for SaMD
- Every day, we collaborate, create, and constantly reimagine what's possible.
Requirements
- Leadership & Functional Expertise
- Experience leading FDA responses, remediation efforts, and inspection readiness activities.
- Strong understanding of FDA regulations, ISO 13485, ISO 14971, and global regulatory requirements.
- Demonstrated ability to influence cross functional stakeholders
- Demonstrated business acumen and ability to connect quality strategy to business outcomes.
- 15+ years of progressive leadership experience in Medical Device Quality and/or Design Quality.
- Proven experience leading Design Quality organizations across the product development lifecycle.
- Demonstrated success building, developing, and leading high-performing teams.
- Technical & Product Development Background
- Expertise in design controls, design transfer, and risk management.
- Experience supporting connected medical devices and prior experience partnering with Software as a Medical Device (SaMD) teams.
- Regulatory & Compliance
- Significant FDA inspection and audit management experience.
- Experience conducting risk-benefit analyses and making quality decisions in highly regulated environments.
- Ways to Stand Out
Compensation
- Estimated Pay Range
Benefits
- Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
- iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease.
- Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.
Company info
- As a part of our core values, we ensure an inclusive workforce.
Equal opportunity
- Equal Opportunity Employer.
- If you need such an accommodation, you may contact us at taops@irhythmtech.com
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This listing is sourced directly from Irhythmtech's careers page and normalized into a canonical job model.