Head of Regulated SaMD Software Engineering

iRhythm; United States; Remote; USD 278,000 - 361,000; Full time

Job summary

iRhythm is seeking a Vice President of Software Engineering to provide executive leadership across regulated software platforms. The role reports to the Senior Vice President of Systems Development and ensures delivery, performance, and scalability to support clinician workflows and connected devices.

The position requires 10+ years leading large software teams, deep regulatory expertise (FDA, IEC 62304, ISO 13485), and a track record delivering SaMD solutions.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or a related technical discipline; advanced degree preferred.
• 10+ years of progressive software engineering leadership experience, including leadership of large‑scale engineering organizations and senior technology leaders.
• Proven track record delivering SaMD solutions within highly regulated medical device environments.
• Deep expertise in FDA software regulations, IEC 62304, ISO 13485, and medical device quality systems.

Responsibilities

• Lead end-to-end software engineering execution across multiple software domains within a regulated SaMD environment.
• Establish engineering operating systems, governance, and development practices for disciplined, transparent delivery.
• Drive continuous improvement to enhance velocity, quality, release confidence, and customer outcomes.
• Ensure lifecycle processes meet regulatory, compliance, and quality standards (FDA, IEC 62304, ISO 13485, cybersecurity, QMS).
• Translate technical concepts and risks into actionable insights for executives and stakeholders.
• Advance CI/CD, platforms, automation, and engineering enablement in regulated medical tech.
• Foster AI-assisted software development governance to accelerate innovation and reduce delivery risk.
• Establish a metrics-driven culture with data-informed decision making.

Job description

iRhythm is seeking a Vice President of Software Engineering to provide executive leadership across regulated software platforms. The role reports to the Senior Vice President of Systems Development and ensures delivery, performance, and scalability to support clinician workflows and connected devices.

The position requires 10+ years leading large software teams, deep regulatory expertise (FDA, IEC 62304, ISO 13485), and a track record delivering SaMD solutions.