iRhythm Technologies, Inc. · 15 hours ago
Senior Software QA Engineer II
United States
Full-time
Remote
Senior Level, Lead/Staff
$135K/yr - $175K/yr
10+ years expiRhythm Technologies, Inc. is a leading digital healthcare company that creates trusted solutions for cardiac health. As a Senior Software QA Engineer II, you will lead verification strategies and ensure compliance with regulatory requirements while collaborating with cross-functional teams to support new product introductions and software releases.
Health CareHealth DiagnosticsMedical DevicemHealthWearables
Responsibilities
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
Provide input to verification time and resource estimates
Reports project status, tracks test metrics and ability to work on multiple projects and meet deadlines
Review and contribute to requirements and design documentation with a focus on quality, accuracy, completeness, and testability
Provide cross-functional support for new product introductions and software releases, including preparation of SQA documentation for regulatory submissions
Define test strategies and effort estimates based on risk and project scope
Work with databases, APIs, and Linux environments to validate data integrity, system behavior, and workflow accuracy
Support end-to-end integration testing of clinical software with upstream/downstream systems, APIs, and data pipelines to ensure end-to-end workflow functionality
Analyze and test production issues, drive root cause investigation, and determine regression test scope based on risk/impact
Collaborate daily with development, product, TPM, and QE partners in Agile teams; participate in stand-ups, sprint planning, and project status meetings
Contribute to DHF activities and ensure timely, high-quality phase deliverables
Mentor junior QA engineers, providing guidance on test methods, compliance documentation, and best practices
Champion quality best practices across Agile teams, driving a culture of early defect prevention and continuous improvement
Partner with test automation engineers/leads to identify and implement test automation opportunities to strengthen regression coverage
Qualification
Required
Bachelor's degree in a technical discipline
10+ years of software QA experience, with 3+ years in medical device or FDA-regulated software development
Experience leading Verification test efforts for medium to large size projects
Demonstrated ownership of DHF deliverables (test plans, protocols, reports, traceability matrices)
Strong understanding of design control procedures and the software development lifecycle in regulated environments
Experience supporting regulatory submissions and audits
Excellent analytical and problem-solving skills with the ability to work independently
Proven track record mentoring or guiding junior QA team members
Effective written and verbal communication skills; strong attention to detail
Hands-on experience with MySQL, Linux, and working in Agile environments
Ability to quickly learn new tools, applications, and technologies
Proven ability to act as a quality advocate within cross-functional teams, influencing design and development decisions to strengthen overall product quality
Preferred
Familiarity with ISO 14971 (risk management) and IEC 62304 a plus
Experience with regression test automation 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
2026-01-07
GlobeNewswire
2025-12-08
Company data provided by crunchbase