Director, 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 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.

Essential Duties and 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.
    

Experience and Minimum Qualifications:

• 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. 
• Experience with AI based devices and/or SaMD and/or wearable medical devices preferred. 
• Master’s or advanced degree preferred
  

What’s In It for You:
This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO!

iRhythm also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, paid parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more!

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 taops@irhythmtech.com

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 taops@irhythmtech.com. 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