Irhythmtech
Staff Software Quality Engineer
Orange County, CA · Staff+
Sponsorship not specified$127k-$165kDetected 30 days ago
AlgorithmsGitJenkinsDevOpsData AnalysisJiraTest AutomationPatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationGxP
About the role
- 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: R eview, approve and occasionally author validation plans, software V&V, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols/reports.
Responsibilities
- NPS Validation Strategy: Define and lead the Computer Software Assurance (CSA) strategy and validation master plans for new and existing non-product software.
- 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.
- Manage software changes, updates, and patches via rigorous configuration management processes.
- Every day, we collaborate, create, and constantly reimagine what's possible.
Requirements
- 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
Skills
- Experience implementing risk-based testing (CSA) and automated testing tools.
- Experience with SaMD / AI-enabled medical devices.
- Soft
- Preferred
- Work Environment / Other
- Apply risk-based testing methodologies to determine the appropriate rigor of validation for manufacturing, QMS, and development tools.
- Knowledge, Skills and Abilities:
- Technical Skills: Experience implementing risk-based testing (CSA) and automated testing tools.
Compensation
- Estimated Pay Range
Benefits
- Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
- iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease.
- Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.
Company info
- As a part of our core values, we ensure an inclusive workforce.
Equal opportunity
- Equal Opportunity Employer.
- If you need such an accommodation, you may contact us at taops@irhythmtech.com
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This listing is sourced directly from Irhythmtech's careers page and normalized into a canonical job model.