Director, Design Quality

Regulatory Jobs; United States; Remote; USD 182,000 - 237,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401K with company match

Paid holidays and PTO

Job summary

iRhythm Technologies is seeking a Director of Design Quality to provide strategic and operational leadership across hardware, firmware, software, connected devices, and AI-enabled products. You will lead Design Quality Engineering teams and partner with R&D, Regulatory, Manufacturing, Clinical, and Quality to ensure development, transfer, and maintenance meet global regulatory requirements.

This role demands expert knowledge of design controls, risk management, and quality systems.

Qualifications

• Minimum of 15 years of related experience in medical/healthcare field
• At least 5 years in a management position with direct reports
• Expert-level knowledge of Design Controls and Risk Management
• Experience with AI based devices and/or SaMD and/or wearable medical devices preferred
• Master’s or advanced degree preferred

Responsibilities

• Lead Design Quality Engineering teams across hardware and software disciplines
• Provide expert oversight of design controls, design transfer, risk management, verification and validation, human factors
• Partner with cross-functional leaders to establish clear quality strategies throughout product lifecycle
• Improve QMS processes, metrics, and governance to increase compliance and efficiency
• Represent Design Quality during FDA inspections, Notified Body audits, and regulatory interactions
• Provide clear reporting on quality risks and priorities to executive leadership

Skills

Design Controls

Risk Management

Leadership/People Management

Cross-functional collaboration

Cybersecurity

Software quality

AI-based devices experience

Education

Bachelor's degree

Master’s degree preferred

Job description

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:

Remote - US

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

Estimated Pay Range

$182,000.00 - $237,000.00

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 [e-mail]

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.