Senior System Engineer I, Lifecycle Engineering at iRhythm Technologies

California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare TechnologyIndustries

Requirements

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

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

Skills

Key technologies and capabilities for this role

Systems EngineeringHardware IntegrationSoftware IntegrationEmbedded SoftwareCloud PlatformsSystem Integration TestingUATE2E TestingTroubleshootingMedical Device ComplianceLifecycle Engineering

Questions & Answers

Common questions about this position

What is the employment type for this Senior System Engineer I role?

The position is full-time employment.

Is this Senior System Engineer I position remote or onsite?

This information is not specified in the job description.

What key skills are required for the Senior System Engineer I role?

The role requires skills in system-level investigations for hardware, software, and cloud platforms, root-cause analysis using methods like FMEA and 8D, authoring V&V test plans compliant with IEC standards, and risk management per ISO 14971.

What is the company culture like at iRhythm Technologies?

iRhythm fosters a collaborative, innovative environment where employees collaborate, create, and reimagine possibilities, driven by a commitment to put patients first, think big, move fast, and improve lives through cardiac health solutions.

What makes a strong candidate for this Senior System Engineer I position?

Strong candidates are highly skilled builders who are curious, innovative problem solvers with experience leading system-level investigations, troubleshooting complex medical device systems, ensuring compliance with standards like IEC 62304 and ISO 14971, and mentoring junior engineers.

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Mental Health Support

Hybrid Work Options

Pet Insurance

Risks

Increased competition from emerging cardiac monitoring technologies threatens market share.

FDA warning letter may lead to regulatory scrutiny and potential fines.

Shareholder investigation could result in legal challenges and financial liabilities.

Differentiation

Zio Patch offers up to 14 days of uninterrupted cardiac monitoring.

iRhythm's Zio Patch is the smallest and least conspicuous cardiac diagnostic device.

The company provides data analysis services for actionable insights from Zio Patch data.

Upsides

Wearable health tech market growth aligns with iRhythm's business model.

Telehealth expansion increases demand for remote monitoring solutions like Zio Patch.

AI integration enhances arrhythmia detection accuracy in iRhythm's Zio Patch.

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