Senior System Engineer I, Lifecycle Engineering
$112k/y-$145k/y
iRhythm Technologies, Inc.a day ago
Highlight
HybridFull-timeSenior
Summary
iRhythm Technologies, Inc. is seeking a Senior System Engineer I, Lifecycle Engineering to join their Product Development team in Cypress, CA. The role focuses on supporting existing products through their lifecycle, ensuring quality, compliance, and continuous improvement.
About the Role
As a Senior System Engineer I, you will lead system-level investigations for commercialized product lines, coordinate testing initiatives, support embedded software development, author and execute V&V test plans, drive root-cause analysis for system failures, maintain system-level documentation, collaborate with manufacturing engineering, ensure risk management compliance, support regulatory submissions, and mentor junior engineers.
About You
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.
Preferred:
- Hands-on experience with embedded software development (C/C++ or similar) and familiarity with real-time operating systems (RTOS).
- Experience with cybersecurity for medical devices and wireless communication protocols (e.g., Bluetooth, Wi-Fi).
- Certification in Lean/Six Sigma or PMP for structured problem-solving and project leadership a plus.
Benefits
- Hybrid work environment with up to 10% travel to the San Francisco facility.
- Inclusive workforce culture that celebrates diverse backgrounds and experiences.
iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. Our Mission Boldly innovate to create trusted solutions that detect, predict, and prevent disease. Our Core Values Lead with integrity; solve for the patient; think big, go fast; collaborate to win; and strive for better.
Cypress, CA