Director, Systems Engineering

iRhythm Technologies, Inc.

Job Overview

Location

Remote - US

Job Type

Full-time

Full Job Description

📋 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) 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.
• 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.

🏖️ Benefits

• Opportunity to impact lives through cardiac health solutions that improve patient outcomes globally
• Remote work flexibility with up to 25% domestic travel primarily to San Francisco Bay Area or Southern California
• Competitive compensation range of $182,000 - $237,000 based on experience and location
• Inclusive workplace culture celebrating diverse backgrounds, experiences, skills, and perspectives
• Equal Opportunity Employer commitment with reasonable accommodations for qualified individuals with disabilities
• Support for professional growth through training, certifications (INCOSE ASEP/CSEP/ESEP or Lean/Six Sigma), and engagement with systems engineering community of practice

Skills & Technologies

Remote

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iRhythm Technologies, Inc.

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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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