Senior Software Quality Assurance Engineer I

Career-defining. Life-changing.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

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.

Location = Remote US

What You Will Be Doing

• 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.