Director, Design Quality
About The Position
The Director of Design Quality provides strategic and operational leadership for design quality across iRhythm’s hardware, firmware, software, connected-device, and AI-enabled product portfolio. The role leads Design Quality Engineering teams and partners closely with R&D, Product Management, Manufacturing, Regulatory, Clinical, and Quality functions to ensure products are developed, transferred, and maintained in compliance with global regulatory requirements. This leader serves as the organization’s design controls and risk management expert, strengthens quality systems and culture, uses post-market insights to prevent recurrence of quality issues, and ensures quality is integrated into business and product-development decisions.
Requirements
- Minimum of 15 years of related experience with a Bachelor’s degree; Related experience includes medical/science/healthcare field; or equivalent.
- At least 5 years of experience in a management position with direct reports.
- Demonstrated expert-level knowledge of Design Controls, Critical-to-Quality strategies, Risk Management, Cybersecurity, etc.
- Demonstrated knowledge of mechanical, electrical and software engineering in the development of complex devices
- Demonstrated knowledge in Software development lifecycle, including familiarity with embedded software and firmware, applications software and analytics; knowledge of software quality for mobile device apps and remote installation is a plus.
- Proven capacity to collaborate and build positive relationships and trust over time with cross-disciplinary audiences.
Nice To Haves
- Experience with AI based devices and/or SaMD and/or wearable medical devices preferred.
- Master’s or advanced degree preferred
Responsibilities
- Lead, develop, and resource Design Quality Engineering teams across hardware and software disciplines.
- Provide expert and leadership oversight of design controls, design transfer, risk management, verification and validation, human factors, and product lifecycle activities.
- Partner with cross-functional leaders to establish clear quality strategies, requirements, decision points, and escalation paths throughout product lifecycle.
- Improve design-related Quality Management System processes, metrics, and governance to increase both compliance and operational effectiveness.
- Apply complaint, field-performance, and post-market data to identify product risks, implement corrective improvements, and prevent recurrence in future designs.
- Represent Design Quality during FDA inspections, Notified Body audits, regulatory interactions, and executive management reviews.
- Ensure compliance with FDA requirements, including the Quality Management System Regulation (21 CFR Part 820) and applicable software and cybersecurity guidance; ISO 13485; ISO 14971; IEC 62304; IEC 82304; IEC 62366, EU MDR, and other applicable international regulations and standards.
- Build and nurture a collaborative, patient- and customer-focused quality culture while influencing organizational change.
- Recruit, coach, and develop high-performing leaders and teams, including succession planning and capability development.
- Provide clear, fact-based reporting to executive leadership on quality risks, performance, resources, and improvement priorities.
- Other assignments as directed by management.
Benefits
- medical, dental, and vision insurance (all of which start on your first day)
- paid holidays
- PTO
- 401K (with company match)
- an Employee Stock Purchase Plan
- paid parental leave
- pet insurance discount
- Cultural Committee/Charity events
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What This Job Offers
Job Type
Full-time
Career Level
Director
