iRhythm Technologies, Inc.-posted 3 months ago
$112,000 - $145,000/Yr
Full-time • Senior
1,001-5,000 employees

The iRhythm Software Quality Assurance team is seeking a Senior Software QA Engineer to partner with software engineering, project management, and design QA in developing and testing arrhythmia detection algorithms and software applications that power iRhythm’s world-class ECG analysis services. In this role, you will own advanced verification efforts in an FDA-regulated environment. You will work independently on complex projects, mentor junior QA engineers, and serve as a quality advocate throughout the software lifecycle, ensuring our clinical tools meet the highest standards of safety, reliability, and regulatory compliance.

  • Own 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.
  • 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.
  • Bachelor’s degree in a technical discipline.
  • 7+ years of software QA experience, with 3+ years in medical device or FDA-regulated software development.
  • 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.
  • Familiarity with ISO 14971 (risk management) and IEC 62304 a plus.
  • Experience with regression test automation a plus.
  • Inclusive workforce culture.
  • Opportunities for career growth and advancement.
  • Remote work options.
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