Director, Design Quality

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $182k - $237k / year

⏰ Full Time

🔴 Lead

🧑‍🎨 Art Director

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iRhythm Technologies, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2006

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

📋 Description

• Lead, develop, and resource Design Quality Engineering teams across hardware and software disciplines • Provide 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 quality strategies, requirements, decision points, and escalation paths • Improve design-related Quality Management System processes, metrics, and governance • Apply complaint, field-performance, and post-market data to identify product risks and prevent recurrence • Represent Design Quality during FDA inspections, Notified Body audits, regulatory interactions, and executive management reviews • Ensure compliance with FDA requirements, international regulations, and medical-device standards • Build and nurture a collaborative, patient- and customer-focused quality culture • Recruit, coach, and develop leaders and teams, including succession planning and capability development • Report quality risks, performance, resources, and improvement priorities to executive leadership • Perform other assignments as directed by management

🎯 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 • Expert-level knowledge of Design Controls, Critical-to-Quality strategies, Risk Management, Cybersecurity, and related disciplines • Knowledge of mechanical, electrical, and software engineering in the development of complex devices • Knowledge of software development lifecycle, including embedded software and firmware, application software, and analytics • Experience with software quality for mobile device apps and remote installation is a plus • Capacity to collaborate and build positive relationships and trust with cross-disciplinary audiences • Experience with AI-based devices, SaMD, and/or wearable medical devices preferred • Master’s or advanced degree preferred • Knowledge of FDA requirements, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 62366, EU MDR, and other applicable international regulations and standards

🏖️ Benefits

• Medical, dental, and vision insurance starting on the first day • Paid holidays • PTO • 401K with company match • Employee Stock Purchase Plan • Paid parental leave • Pet insurance discount • Cultural Committee/Charity events • Reasonable accommodations for qualified individuals with disabilities in job application procedures