Job Overview
Location
Remote - US
Job Type
Full-time
Category
Data Science
Date Posted
June 6, 2026
Full Job Description
đź“‹ Description
- • Lead and scale the Design Quality organization across hardware, software (SaMD), and risk management functions to ensure global regulatory compliance and scalable innovation.
- • Provide strategic and operational leadership for all design quality activities throughout the product lifecycle—from early feasibility through commercialization and post-market changes.
- • Serve as the primary point of accountability for FDA inspections, Notified Body audits, and regulatory remediation efforts, including responses to FDA warning letters.
- • Establish and continuously improve Design Control, Design Transfer, and Risk Management processes aligned with ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971.
- • Embed quality and regulatory considerations into product portfolio strategy, R&D development programs, and lifecycle management to enable innovation while maintaining compliance.
- • Partner closely with R&D, Clinical, Regulatory, Operations, Manufacturing, and Commercial teams to ensure alignment on quality expectations and regulatory requirements.
- • Drive integration of quality engineering principles—including verification/validation, clinical evaluations, risk analysis, human factor analysis, and product validation—into agile and AI/algorithm development environments for SaMD.
- • Transform and harmonize Design Quality processes within the Quality Management System (QMS) to create a sustainable, inspection-ready state across all product lines.
- • Establish metrics, dashboards, and governance mechanisms to monitor product quality, design process effectiveness, and compliance performance.
- • Lead cross-functional initiatives to improve product development efficiency, reduce time-to-market, and enhance quality outcomes without compromising regulatory standards.
- • Oversee the enterprise product risk management function, ensuring alignment with ISO 14971 and embedding risk-based decision-making across all stages of product development and lifecycle management.
- • Strengthen linkages between risk management, clinical evaluation, and post-market surveillance data to support proactive quality improvements and regulatory submissions.
- • Translate evolving global regulatory requirements into scalable internal procedures, systems, and training programs to ensure organizational readiness.
- • Influence product development strategy through risk-informed and compliance-driven decision-making, acting as a strategic business partner to executive leadership.
- • Build, develop, and retain a high-performing Design Quality team with strong talent development, succession planning, and capability-building initiatives.
- • Support portfolio prioritization and innovation efforts by providing quality insights that balance regulatory rigor with business growth objectives.
- • Ensure effective quality oversight for new product introduction and global product transfers, including harmonization of processes across geographies.
- • Champion a culture of quality, accountability, and continuous improvement across all product development functions.
🎯 Requirements
- • 15+ years of progressive leadership experience in Medical Device Quality and/or Design Quality
- • Proven experience leading Design Quality organizations across the full product development lifecycle
- • Expertise in design controls, design transfer, and risk management under ISO 13485, FDA 21 CFR Part 820, and ISO 14971
- • Significant experience managing FDA inspections, audits, and regulatory remediation efforts
- • Demonstrated success building and leading high-performing cross-functional teams in regulated environments
- • Experience supporting connected medical devices and Software as a Medical Device (SaMD) teams
🏖️ Benefits
- • Estimated pay range of $266,000.00 - $346,000.00
- • Remote work arrangement with US-only eligibility
- • Opportunity to impact global cardiac health through innovative digital healthcare solutions
- • Inclusive workplace culture that celebrates diverse backgrounds and perspectives
- • Equal opportunity employer considering qualified applicants with arrest and conviction records
- • Reasonable accommodations available for individuals with disabilities during the application process
Skills & Technologies
Remote
About iRhythm Technologies, Inc.
iRhythm Technologies, Inc. provides FDA-cleared cardiac monitoring solutions that use wearable biosensor technology and cloud-based data analytics to detect arrhythmias. The Zio patch records continuous ECG for up to 14 days, while proprietary algorithms analyze millions of heartbeat data points to generate clinical reports for physicians. The company serves hospitals, clinics, and healthcare systems aiming to improve diagnostic accuracy and reduce stroke risk associated with undiagnosed atrial fibrillation.
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