Apply

Ready to go for it?

AI Apply speeds things up—apply directly if you prefer.

FREE ACCESS
5,000–10,000 jobs/day
Scoutfield Logo

See all jobs on Scoutfield

Search thousands of fresh jobs every day.

Discover
  • Fresh listings
  • Fast filters
  • No subscription required
Create a free account and start exploring right away.
iRhythm Technologies, Inc.

Director, Design Quality

iRhythm Technologies, Inc.

. Lead, develop, and resource Design Quality Engineering teams across hardware and software disciplines .

Posted 10/13/2026full-timeRemote • United StatesLead💰 $182,000 - $237,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in Design Quality Engineering, including leadership in design controls, risk management, and compliance with FDA and international medical device standards. Proven ability to foster a collaborative quality culture while managing cross-functional teams and driving quality improvement initiatives.

Highest-signal resume keywords
Design ControlsRisk ManagementFDA ComplianceQuality Management SystemLeadership Development

ATS Keywords

Tailor your resume
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Design Quality EngineeringRisk ManagementSoftware Development LifecycleCybersecurityMechanical EngineeringElectrical EngineeringEmbedded SoftwareApplication SoftwareAI-Based DevicesWearable Medical Devices
Soft Skills
CollaborationRelationship BuildingCoachingTrust BuildingLeadership
Certifications & Qualifications
Bachelor’s DegreeMaster’s DegreeISO 13485ISO 14971IEC 62304IEC 82304IEC 62366EU MDR
Industry Keywords
Medical Device Standards21 CFR Part 820SaMDQuality MetricsRegulatory Interactions

Tech Stack

Tools & technologies
Cyber Security

About the role

Key responsibilities & impact
  • 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

What you’ll need
  • 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

Comp & perks
  • 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