VP of SaMD Software Engineering — Remote Leader

El Camino Health

Northern (KY)

Remote

USD 278,000 - 361,000

Full time

5 days ago

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Job summary

iRhythm is seeking a Vice President of Software Engineering to provide executive leadership for regulated SaMD platforms. The role reports to the Senior VP of Systems Development and focuses on scalable software delivery, regulatory compliance, and strategic technology direction.

You will partner with Product Security, Quality, Regulatory, and IT to ensure successful delivery and governance across the portfolio, including AI-enabled development practices and data-driven decision making.

Qualifications

Progressive software engineering leadership experience in regulated environments.
Experience delivering SaMD solutions from concept through post-market support.
Deep expertise in FDA software regulations and medical device quality systems.

Responsibilities

Lead end-to-end software engineering delivery across clinical, patient-facing, platform, and device-integrated systems in a regulated SaMD environment.
Establish and evolve operating systems, governance, and development practices for disciplined planning and delivery.
Drive regulatory compliance, quality standards, and risk management across the software portfolio.
Translate technical concepts and risks into clear executive insights for stakeholders.
Advance CI/CD, automation, and engineering enablement in regulated environments.