Software Engineer II, Lifecycle Engineering at iRhythm Technologies

California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

BS in Computer Engineering, Computer Science, or related field
3+ years of experience in embedded software development (C/C++), including hardware bring-up, low-level drivers, and board-level debugging within the medical device or regulated industry (manufacturing support a plus)
Strong testing discipline: unit/integration/system testing, test automation, static analysis, code reviews, and documented V&V deliverables
Ability to understand and modify different programming languages

Responsibilities

Own software changes across released manufacturing equipment including bug fixes, minor feature enhancements, refactors, and obsolescence-driven updates working within established design controls and change management processes
Lead software updates to manufacturing test systems (fixture software, functional test scripts, ICT/boundary scan integration) and drive improvements to yield, throughput, and reliability
Integrate embedded firmware with hardware (board bring-up, driver updates, peripheral interfaces), using oscilloscopes, logic analyzers, JTAG/SWD, and in-circuit debuggers for root cause and verification
Lead firmware/software investigations for field returns, NCRs, and deviations; perform structured root cause analysis; implement and verify CAPA actions with clear traceability
Author and execute V&V (unit/integration/system), including test plans, protocols, automated regression suites, and reports compliant with IEC 62304 and internal SOPs
Maintain configuration management (requirements, code, test assets, DHF/DMR updates, SBOMs), ensuring complete documentation and traceability through release
Perform risk management activities (ISO 14971), update hazard analyses, perform impact assessments for changes, and ensure risk controls remain effective post-change
Validate software used in production (CSV/IQ/OQ/PQ as applicable), ensuring alignment with 21 CFR 820.70(i) and Part 11 for electronic records/signatures
Collaborate cross-functionally with Hardware, Quality, Regulatory, Manufacturing, Supply Chain, and external suppliers/CMs to plan and execute changes with minimal disruption
Support embedded software development and updates, ensuring compatibility with hardware and compliance with IEC 62304 and cybersecurity requirements
Contribute to secure product maintenance by assessing and implementing vulnerability patches, managing third-party dependencies current in line with evolving guidance

Skills

Key technologies and capabilities for this role

Embedded FirmwareSoftware EngineeringDesign ControlsChange ManagementManufacturing Test SystemsFixture SoftwareFunctional Test ScriptsICTBoundary ScanRegulatory ComplianceC++Python

Questions & Answers

Common questions about this position

What is the employment type for this Software Engineer II position?

The position is full-time employment.

Is this Software Engineer II role remote or office-based?

This information is not specified in the job description.

What key skills are required for the Software Engineer II role?

The role requires skills in embedded firmware and software engineering, integration with hardware using tools like oscilloscopes and JTAG/SWD, root cause analysis, V&V testing compliant with IEC 62304, and configuration management.

What is the company culture like at iRhythm Technologies?

iRhythm fosters a collaborative, innovative environment where employees collaborate, create, think big, move fast, and put patients first to improve lives.

What makes a strong candidate for this Software Engineer II position?

Strong candidates are curious, innovative problem solvers skilled in sustaining engineering for medical devices, with experience owning firmware changes, leading investigations, and ensuring regulatory compliance within design controls.

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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