iRhythm Technologies, Inc. · 3 days ago
Senior System Engineer I, Lifecycle Engineering
Orange County, CA
Full-time
Hybrid
Mid, Senior Level
$112K/yr - $145K/yr
5+ years expiRhythm Technologies, Inc. is a leading digital healthcare company that creates trusted solutions for cardiac health. The Senior System Engineer I will support existing products through their lifecycle, ensuring quality and compliance while leading troubleshooting and design improvements for complex medical device systems.
Health CareHealth DiagnosticsMedical DevicemHealthWearables
Responsibilities
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
Qualification
Required
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
Preferred
Knowledge of signal integrity analysis, power management, and thermal design for embedded systems a plus
Certification in Lean/Six Sigma or PMP for structured problem-solving and project leadership a plus
Company
iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease.
1001-5000 employees
H1B Sponsorship
iRhythm Technologies, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (10)
2022 (9)
2021 (16)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$1.18BKey Investors
BraidwellNovo HoldingsNorwest
2024-03-04Post Ipo Debt· $643.6M
2020-08-21Post Ipo Secondary· $220M
2019-09-11Post Ipo Equity· $115M
Leadership Team
Quentin Blackford
Chief Executive Officer
Mark Day
Chief Technology Officer
Recent News
GlobeNewswire
2025-12-08
Company data provided by crunchbase