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:
About This Role:
The Staff Software Quality Engineer for Non-Product Software (NPS) will be the technical lead and subject matter expert (SME) responsible for the strategy, validation, and compliance of software tools used in the development and manufacturing of Medical Device.
This role ensures that all software applications supporting GxP business processes, software for tools and fixtures used for device manufacturing and processing, and software development/testing tools (e.g., Jira, Jenkins, GitHub) are validated according to the latest FDA Computer Software Assurance (CSA) guidance and ISO 13485 standards.
Essential Duties and Responsibilities:
- NPS Validation Strategy: Define and lead the Computer Software Assurance (CSA) strategy and validation master plans for new and existing non-product software.
- Risk Management: Apply risk-based testing methodologies to determine the appropriate rigor of validation for manufacturing, QMS, and development tools.
- Compliance Leadership: Ensure all NPS activities comply with 21 CFR Part 11 (electronic records/signatures) and ISO 13485.
- Documentation Oversight: Review, approve and occasionally author validation plans, software V&V, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols/reports.
- Tool Qualification: Lead the qualification of software-based test, manufacturing and processing equipment, automated data processing systems, and design tools.
- Cross-functional Collaboration: Partner with Manufacturing, IT, DevOps, and R&D teams to identify software needs and implement compliant workflows.
- Audit Readiness: Act as the technical lead for NPS during internal and external audits (FDA, ISO, Notified Bodies).
- Change Control: Manage software changes, updates, and patches via rigorous configuration management processes.
Experience and Minimum Qualifications:
- Typically requires a minimum of 12 years of related experience with a Bachelor's degree in Computer Science, Biomedical Engineering, or related technical field; or 8 years and a Master's degree; or equivalent work experience.
Knowledge, Skills and Abilities:
- Regulatory Knowledge: Deep understanding of FDA 21 CFR Part 820, Part 11, IEC 62304 standards and GAMP5.
- NPS Expertise: Demonstrated experience with validating custom software, tools and fixtures for device manufacturing and processing, DevOps toolchains (e.g., Jira, Git), test automation, and/or GxP applications supporting QMS and other GxP business processes.
- Technical Skills: Experience implementing risk-based testing (CSA) and automated testing tools.
- Soft Skills: Proven ability to lead cross-functional projects, mentor junior engineers, and communicate complex compliance requirements to technical and non-technical stakeholders.
- Preferred skills: Experience with SaMD / AI-enabled medical devices.
Work Environment / Other Requirements:
- iOC based
- Hybrid role with a minimum of 3 days on site
Location:
Orange CountyActual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$127,000.00 - $165,000.00As 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
