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.
Requirements
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.
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
Si
Benefits
Health insurance
Additional Information
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.
Irhythmtech · Remote