Senior Software Quality Assurance Engineer I

iRhythm Technologies, Inc.

148d • $112,000 - $145,000

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Inclusive workforce culture.
• Opportunities for career growth and advancement.
• Remote work options.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees