Director, Systems Engineering

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🕒 May 18

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iRhythm Technologies, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2006

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Technology

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 mentor multidisciplinary Systems Engineering and Test teams supporting product development of cardiac diagnostic technologies from concept through commercial launch, as well as sustaining and lifecycle engineering activities. • Own functional strategy, execution priorities, resource planning, and operating model for Systems Engineering, ensuring alignment with business priorities and portfolio roadmaps. • Serve as an effective change agent by driving adoption of improved engineering processes, tools, and best practices while maintaining team engagement, compliance standards, and organizational momentum. • Lead system-level requirements management, ensuring user needs are translated into clear, testable, traceable, risk-informed product, system, subsystem, software, hardware, firmware, and verification requirements. • Communicate project status, risks, budget, resource needs, and execution priorities to executive leadership in a clear, concise, and actionable manner. • Provide leadership support of external vendor partnerships, engineering evaluations, and verification testing of design changes as required. • Partner cross-functionally with RA/QA, Product Management, Operations, Clinical, Manufacturing, and R&D functions to ensure design inputs and outputs meet regulatory, quality, customer, patient, user, and business needs. • Sponsor a Systems Engineering community of practice, bringing industry best practices, training, standards awareness, and engagement with the broader systems engineering community (INCOSE, AAMI, MDIC, etc). • Provide key planning inputs to ensure resource management, timelines, and budgets meet program and business needs. • Provide oversight and targeted participation in QMS improvement initiatives, including DOP/SOP authoring and maintenance, to help ensure engineering processes are robust, efficient, compliant, and executable. • Support regulatory inquiries, audits, inspections, and technical discussions, as required.

🎯 Requirements

• BS in Systems Engineering, Electrical Engineering, Biomedical Engineering or related engineering degree; MS/MBA a plus • 15+ years in regulated medical device development (Class II/III Connected) with deep experience in Systems Engineering across NPI and sustaining/lifecycle in regulated manufacturing environments. • 8+ years of people leadership managing and developing multidisciplinary engineering teams (Systems Engineering; HW/FW/SW/mechanical integration) • Expertise in systems engineering best practices: user needs → system/subsystem requirements, architecture, interface definition/control, requirements traceability, and configuration management. • Experience developing medical device platforms that include hardware, firmware and tools/fixtures that interface with devices and/or data in a safe and secure way. • Working knowledge of applicable regulatory standards and requirements, including FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 as applicable. • Proven leadership of system-level risk management and design change execution in medical device development, including hazard analysis, dFMEA/pFMEA/uFMEA, impact assessments, V&V/regulatory strategy alignment, and design transfer support. • Proven ownership of verification strategy and execution, including test planning, protocol/report oversight, coverage and traceability management, and ensuring robust evidence for product releases and design changes. • Strong executive communication and cross-functional leadership, including vendor/partner governance, prioritization across multiple programs, and structured problem-solving (RCA/CAPA support) • Experience supporting global regulatory submissions and responses, including FDA, EU MDR, and international submissions, with technical content and objective evidence.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options