Director of MedTech Software Testing & Automation

Edwards Lifesciences; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences is seeking a Director of Software Systems, Process & Delivery in Irvine, CA. Lead the IHFM software delivery, release readiness, and design-control processes ensuring audit-readiness across patient-focused products.

In this high-impact role you will drive test strategy, automate verification, and coordinate cross-functional teams to meet regulatory requirements and quality standards while partnering with hardware, firmware, and cloud components.

Qualifications

• Experience in software testing and test automation, including independently writing test cases and automated tests.
• Working knowledge of the software development lifecycle, structured testing methodologies, and software risk management principles.
• Proficiency with at least one automation framework and language (e.g., Selenium, Appium, Python) and experience integrating tests into CI/CD (e.g., GitLab CI, GitHub Actions, Azure Pipelines).
• Experience in regulated medical device environments and familiarity with FDA quality system requirements, IEC 62304, ISO 13485, or ISO 14971 is a plus.

Responsibilities

• Design and execute software test plans, protocols, and cases, and build automated tests for IHFM features.
• Develop and maintain automated tests (UI, API, data-pipeline) and integrate them into CI/CD pipelines.
• Perform functional, regression, and integration testing and verify against external systems like EMR/EHR.
• Manage defects and test artifacts in Azure DevOps and coordinate fixes with developers.
• Produce test documentation that meets FDA/IEC/ISO audit expectations.
• Validate Bluetooth/BLE and device interoperability with Android/iOS apps and hardware.

Skills

Software testing

Test automation

Documentation

Cross-functional teamwork

Attention to detail

Education

Bachelor’s degree in Engineering/CS/BME or related

Master’s degree or equivalent

Tools

Selenium

Appium

Python

Azure Pipelines

GitLab CI

GitHub Actions

Azure DevOps

Job description

Edwards Lifesciences is seeking a Director of Software Systems, Process & Delivery in Irvine, CA. Lead the IHFM software delivery, release readiness, and design-control processes ensuring audit-readiness across patient-focused products.

In this high-impact role you will drive test strategy, automate verification, and coordinate cross-functional teams to meet regulatory requirements and quality standards while partnering with hardware, firmware, and cloud components.