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.
About You
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 62
Benefits
Health insurance
Additional Information
Career-defining. Life-changing.
At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
About This Role:
Role Summary
iRhythm is a leading designer and manufacturer of ambulatory cardiac monitoring wearable technologies, providing an end-to-end service that delivers a best-in-class wear experience, high reliability, and strong clinical value for patients and healthcare providers. At iRhythm, we start by solving for the patient and execute by thinking big and going fast, leading with integrity, collaborating to win, and always striving for better.
To continue advancing this mission, we are seeking a Director, Systems Engineering to join our organization, reporting to the Vice President of Product Development. This leader will oversee the Systems Engineering and Test functions within a regulated medical device product development environment.
The Director will provide strategic direction, technical leadership, and organizational capability-building across new product development and lifecycle management for connected cardiac monitoring technologies. This role will ensure teams apply disciplined systems engineering practices, including requirements management, architecture definition, interface control, risk management, verification strategy, design controls, and traceability. This leader will bring industry best practices into the organization, strengthen engineering rigor, and help ensure iRhythm's products remain safe, effective, scalable, and compliant throughout their lifecycle.
Irhythmtech · Remote