Senior System Engineer , Lifecycle Engineering

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.

iRhythm's Product Development team is seeking a highly skilled Senior System Engineer I to join our Lifecycle (Sustaining) Engineering team. This role focuses on supporting existing products through their lifecycle, ensuring quality, compliance, and continuous improvement while maintaining business continuity. In this role, you will support the lifecycle of complex medical device systems by integrating hardware, software, and mechanical components. You will lead troubleshooting, design improvements, and system-level changes to ensure compliance, reliability, and manufacturability.

You'll play a pivotal role within iRhythm's Lifecycle Engineering (LCE) Center of Excellence, charting the course for the company's capabilities, and collaborating with cross-functional teams. This opportunity offers substantial career growth potential while positively impacting lives through design and technology.

• Lead system-level investigations for commercialized product lines, focusing on hardware, software, and cloud platforms to maintain product performance and compliance.
• Coordinate and lead testing initiatives for system integration (SIT), UAT across manufacturing, cloud and enterprise platforms (E2E testing)
• Support embedded software development and updates, ensuring compatibility with hardware, software interfaces, cloud interfaces, and compliance with IEC 62304 and cybersecurity requirements.
• Author and execute V&V test plans, protocols, and reports compliant with applicable IEC standards and internal SOPs.
• Drive root-cause analysis for complex system failures using structured methods (e.g., FMEA, 8D, fault tree analysis) and implement effective corrective actions.
• Maintain system-level documentation across core hardware products (architecture diagrams, interface control documents, requirements traceability) in compliance with design control regulations.
• Collaborate with manufacturing engineering to resolve production issues, improve yields, and validate process changes impacting system performance.
• Ensure risk management compliance by updating system-level hazard analyses and FMEAs per ISO 14971.
• Support regulatory submissions, assessments and audits by providing technical justifications, change impact assessments, and system-level documentation.
• Mentor junior engineers in systems thinking, integration practices, and sustaining engineering processes.

• BS degree in Engineering (Electrical, Biomedical, Systems), MS degree a plus.
• 5+ years of system engineering experience in medical device manufacturing or sustaining engineering (Class II/III environment preferred).
• Strong knowledge of PCBA design principles, embedded systems, and hardware/software integration.
• Proficiency in system verification and validation, including test planning, execution, and tracing documentation under design control.
• Strong understanding of FDA QSR, ISO 13485, IEC 60601, ISO 14971 and IEC 62304 standards.
• Demonstrated validation and problem-solving capability; hands‑on root cause and CAPA execution for product and process issues.
• Hands‑on experience with embedded software development (C/C++ or similar) and familiarity with real‑time operating systems (RTOS).
• Ability to navigate competing priorities and technical disagreements constructively.
• Experience with cybersecurity for medical devices and wireless communication protocols (e.g., Bluetooth, Wi‑Fi).
• Proven management of engineering change orders in PLM.
• MS Office suite including Project/Smartsheet.
• Knowledge of signal integrity analysis,…