Vice President, Product Design Quality

iRhythm Technologies, Inc. is a leading digital healthcare company focused on cardiac health solutions. The Vice President, Product Design Quality will lead the Design Quality organization, ensuring compliance with regulatory requirements and driving quality throughout the product lifecycle from development to commercialization.

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
• 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
• 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
• 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

Requirements:

• 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