Software Quality Engineer

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.

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, Git Hub) are validated according to the latest FDA Computer Software Assurance (CSA) guidance and ISO 13485 standards.

• 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, Dev Ops, 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.

• 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.

• Regulatory Knowledge:
  Deep understanding of FDA 21 CFR Part 820, Part 11, IEC 62304 standards and GAMP
  5.
• NPS Expertise:
  Demonstrated experience with validating custom software, tools and fixtures for device manufacturing and processing, Dev Ops tool chains (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.

• iOC based
• Hybrid role with a minimum of 3 days on site

Orange County

$ - $

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