Teams at iRhythm Technologies

Leads complex embedded hardware and firmware development projects from concept through production and commercialization. Owns project planning, schedules, resources, risks, documentation, design-control release plans, and cross-functional execution. Acts as scrum master, facilitates technical discussions, coordinates engineering, quality, regulatory, manufacturing, clinical, and commercial teams, and ensures compliance with company and international standards. Supports production release, project health monitoring, and continuous process improvement for medical device products.

Supports medical device product development from concept through commercialization and post-market evaluation. Leads design controls, risk management, verification and validation, design history files, traceability, risk assessments, change evaluations, technical reporting, and audit support. Partners with hardware, firmware, software, and engineering teams to ensure compliance with quality systems, medical device regulations, and standards including IEC 60601, IEC 62366, IEC 62304, ISO 13485, and ISO 14971.

Lead daily operations of a 20–25 person clinical services team, drive KPIs and performance improvements, manage staffing and budgets, ensure FDA and regulatory compliance, oversee escalation and customer recovery, implement workflow automation and dashboards, coach staff, coordinate training, and contribute to strategic and cross-functional continuous improvement initiatives.