Director, Regulated Software Testing & Automation

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

Job summary

Edwards Lifesciences in Irvine, CA seeks a Director, Software Systems, Process & Delivery to lead the IHFM software delivery and design-control discipline. You will own release readiness, traceability, and audit-ready processes across digital ecosystem apps, microservices, and data pipelines while collaborating with cross-functional teams in a high-impact medtech hub.

This role emphasizes V&V under design controls, FDA/IEC/ISO compliance, and strong partnerships with development, QA, and

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related field with 2+ years of relevant industry experience.
• Experience in software testing and/or test automation, including independently writing test cases and automated tests, and developing or executing test documentation.
• 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).

Responsibilities

• Design and execute software test plans, protocols, and cases, and build the corresponding automated tests for IHFM features across digital ecosystem apps, platform, and data pipelines.
• Develop and maintain automated tests (UI, API, data-pipeline) and integrate them into CI/CD pipelines to grow regression coverage.
• Perform functional, regression, and integration testing, including integrations with EMR/EHR systems.
• Perform verification and validation under established design controls with traceability from requirements to defects.
• Manage software defects and test artifacts in Azure DevOps; collaborate with developers to reproduce and confirm fixes.
• Produce software test documentation that meets FDA, IEC 62304, and ISO 13485 expectations and audit readiness.
• Validate Bluetooth/BLE communications between medical peripherals and Android/iOS devices.
• Validate interactions between embedded firmware and hardware components.
• Perform integration testing across the complete connected-device workflow.

Skills

Software testing

Test automation

CI/CD integration

Analytical skills

Documentation

Cross-functional collaboration

Bluetooth/BLE testing

Education

Bachelor’s degree in Engineering/CS/Biomedical Eng

Master’s degree or equivalent

Tools

Azure DevOps

Jira

Jama

Codebeamer

Helix ALM

TestRail

Job description

Edwards Lifesciences in Irvine, CA seeks a Director, Software Systems, Process & Delivery to lead the IHFM software delivery and design-control discipline. You will own release readiness, traceability, and audit-ready processes across digital ecosystem apps, microservices, and data pipelines while collaborating with cross-functional teams in a high-impact medtech hub.

This role emphasizes V&V under design controls, FDA/IEC/ISO compliance, and strong partnerships with development, QA, and