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:
What You Will Be Doing
As a Senior Software QA Engineer II, you 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.
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.
What We Need To Stay
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.
Familiarity with ISO 14971 (risk management) and IEC 62304 a plus.
Experience with regression test automation a plus.
Location:
Remote - USActual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$135,000.00 - $175,000.00As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [email protected]
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.
Make iRhythm your path forward. Zio, the heart monitor that changed the game.
There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121
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