Vice President, Product Design Quality

Career-defining. Life-changing. 

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This 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.

This role provides strategic and operational leadership for all design quality activities across the product lifecycle from early feasibility through commercialization and post-market changes ensuring compliance with global regulatory requirements and enabling scalable innovation.

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.

This role is critical to ensuring the organization delivers safe, effective, and compliant products while enabling innovation and growth.

Responsibilities:

Strategic Leadership & Organizational Development

• 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.
• Ensure quality and regulatory considerations are embedded in product portfolio strategy, product development, and lifecycle management.
• 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.
• Influence product development strategy through risk-informed and compliance-driven decision making.

Design Quality & Product Lifecycle Management

• Provide quality and regulatory leadership throughout product development, verification/validation, and commercialization.
•  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.
• Ensure robust quality oversight from concept through commercialization, including new product introduction and global product transfers.
• Drive integration of quality into agile and AI/algorithm development environments for SaMD
• Ensure effective application of quality engineering principles (verification/validation, clinical evaluations, risk analysis, human factor analysis, product validation, etc.).
• Drive transformation and harmonization of Design Quality processes within the Quality Management System (QMS).
•  Establish metrics, dashboards, and governance mechanisms to monitor product quality and design process effectiveness.
• Lead cross-functional initiatives to improve product development efficiency, compliance, and quality outcomes.
• Ensure alignment between design & risk quality, manufacturing quality, and post-market surveillance
• Support portfolio prioritization and innovation efforts with quality insights.
• Serve as the lead for FDA inspections and Notified Body audits, as it relates to design controls, and risk management.
• Translate evolving regulatory design control requirements into scalable internal procedures and systems.

Risk Management & Governance

•  Oversee enterprise product risk management function, ensuring alignment with ISO 14971.
• Ensure risk-based decision-making is embedded across product development and lifecycle management.
• Strengthen linkages between risk management, clinical evaluation, and post-market data.

Leadership & Functional Expertise

• 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.

• 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.

• Significant FDA inspection and audit management experience.
• Experience leading FDA responses, remediation efforts, and inspection readiness activities.
• Strong understanding of FDA regulations, ISO 13485, ISO 14971, and global regulatory requirements.
• Experience conducting risk-benefit analyses and making quality decisions in highly regulated environments.

• Cardiovascular medical device experience.
• Experience supporting AI-enabled products or digital health technologies.
• Demonstrated ability to influence cross functional stakeholders; executive communication skills
• Demonstrated business acumen and ability to connect quality strategy to business outcomes.

Location:

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [email protected]

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121