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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Design Quality Engineer - **Company:** iRhythm Technologies, Inc. - **Location:** San Francisco, CA, United States - **Experience:** Expert - **Salary:** $138,000.0 - $180,000.0 - **Contract:** Permanent contract - **Skills:** JIRA, Embedded Software, Firmware, Software Engineering, Verification and Validation (Software), Test Management, Jama (Software), Information Technology - **Published:** August 29, 2026 - **Apply:** https://jobs.localjobnetwork.com/apply/add/88186485/1 ## About the Role * Bachelor's degree in Computer Science, Software, Computer, Electrical, Mechanical or Biomedical Engineering. * Minimum of 5 years of experience in Quality Assurance of class II or III products with embedded software in the medical device field. * Demonstrated competency of 21 CFR 820, ISO13485, ISO14971 and other international standards. * Solid understanding of design control and risk management from early design and development through commercialization. * Demonstrated experience with electromechanical systems from concept through launch is preferred. * Proficiency in using tools for documentation, defect tracking, and test management (e.g., Jira). * Able to navigate the quality system with minimal oversight on projects Ways to Stand Out * Understands and can subsequently explain complex quality details to non-experts. * Exceptional organizational skills. * Solves complex problems with minimal oversight. * Balanced risk-based decision making to drive product quality, gain consensus, and work through technical challenges. * Demonstrated competency of IEC 62304, and other international standards * Experience using Master Control, Jira, and JAMA is preferred. ## Description A Senior Design Quality Engineer is responsible for supporting product development teams at iRhythm. In this role you will provide hands-on technical engineering support from concept through commercialization and post-market evaluation. The Senior Design Quality Engineer serves as a core team member on cross-functional hardware, firmware, stand-alone software product development projects and provide expertise and guidance to the team on design control and risk management. In this position, you will play a key role in ensuring that products meet quality standards consistent with iRhythm's quality processes, and all external design control and regulatory requirements. This position is hybrid with a weekly onsite requirement of 2 days/week in San Francisco What you'll be doing: * Contribute to the planning and execution of design controls, risk management, and design verification and validation for iRhythm products. * Participate and support the development of product design history file and ensure compliance to internal processes and external standards and regulations. * Partner with engineering to define design inputs, design outputs, and traceability matrices. * Contribute to the strategy and execution of risk-based design verification and validation. * Participate and support the development of product risk management file, to examine and assess the product risks associated with user, design, process, and supplier. * Review design architectures, selections, requirements, and drawings from early design concepts. * Apply knowledge of IEC 60601, IEC 62366, and IEC 62304 to product development projects. * Serve as a technical resource for assessing validation requirements, solving test-related problems, and developing preventive strategies. * Perform and lead risk assessments in support of verification and validation activities * Assist technical teams in the assessment of design changes; including assessment, planning, verification and validation of the change and documentation as required. * Produce technical reports to support product changes or quality assurance investigations. * Support internal and external audits, including preparation and direct interaction with auditors. * Perform other quality-related duties as assigned. ## Related Videos - [Improving quality with Agentic AI with Rovo Dev and Xray](https://www.wearedevelopers.com/videos/2005-improving-quality-with-agentic-ai-with-rovo-dev-and-xray) - [A Developer's Framework for Any Tool Migration](https://www.wearedevelopers.com/videos/2035-a-developer-s-framework-for-any-tool-migration) - [Let’s Talk Quality!](https://www.wearedevelopers.com/videos/100012-let-s-talk-quality) - [Playing Pong on a shoulder press machine](https://www.wearedevelopers.com/videos/100140-playing-pong-on-a-shoulder-press-machine) - [AI as a Test Designer: Transforming Experience into Automated Testing](https://www.wearedevelopers.com/videos/1984-ai-as-a-test-designer-transforming-experience-into-automated-testing) - [AIQSpecFlow: Improves and automates your agile process of specification and creation of testcases.](https://www.wearedevelopers.com/videos/100084-aiqspecflow-improves-and-automates-your-agile-process-of-specification-and-creation-of-testcases) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs)