[Remote] Senior Software QA Engineer II at iRhythm Technologies

United States

iRhythm Technologies Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Healthcare TechnologyIndustries

Requirements

Candidates must possess a Bachelor's degree in a technical discipline and over 10 years of software QA experience, including at least 3 years in medical device or FDA-regulated software development. A proven track record of leading verification test efforts for medium to large projects, demonstrated ownership of DHF deliverables, and a strong understanding of design control procedures and the software development lifecycle in regulated environments are essential. Experience supporting regulatory submissions and audits, excellent analytical and problem-solving skills, and the ability to work independently are required. Proven ability to mentor junior QA team members, effective written and verbal communication skills with strong attention to detail, and hands-on experience with MySQL, Linux, and Agile environments are necessary. The ability to quickly learn new tools, applications, and technologies, and to act as a quality advocate within cross-functional teams is also required. Familiarity with ISO 14971 and IEC 62304, along with experience in regression test automation, are considered a plus.

Responsibilities

The Senior Software QA Engineer II will own and lead the design and execution of verification strategies, including test plans, protocols, reports, and traceability matrices, in compliance with FDA, IEC 62304, and ISO 13485 requirements. They will provide input to verification time and resource estimates, report project status, and track test metrics, while working on multiple projects and meeting deadlines. Responsibilities include reviewing and contributing to requirements and design documentation, providing cross-functional support for new product introductions and software releases, and preparing SQA documentation for regulatory submissions. The role involves defining test strategies and effort estimates based on risk and project scope, working with databases, APIs, and Linux environments to validate data integrity, system behavior, and workflow accuracy, and supporting end-to-end integration testing of clinical software. Analyzing and testing production issues, driving root cause investigations, and determining regression test scope are key duties. The engineer will collaborate daily with development, product, TPM, and QE partners in Agile teams, participate in stand-ups, sprint planning, and project status meetings, and contribute to DHF activities. Mentoring junior QA engineers and championing quality best practices across Agile teams are also part of the role, along with partnering with test automation engineers to identify and implement automation opportunities.

Skills

QA
Test Planning
Test Execution
Test Protocols
Test Reports
Traceability Matrices
FDA Compliance
IEC 62304
ISO 13485
Risk Assessment
Databases
APIs
Linux
Data Integrity
System Behavior
Workflow Accuracy
Integration Testing
Data Pipelines
Root Cause Analysis
Regression Testing
Agile
Software Development Lifecycle

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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