Senior MedTech Test & Automation Engineer

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

Benefits offered by this job

Competitive salary

Performance incentives

Benefits program

Job summary

Edwards Lifesciences in Irvine, CA seeks a Director for Software Systems, Process & Delivery to lead the IHFM software and data product delivery. You will own release readiness, design controls, and audit readiness while collaborating across cross-functional teams.

You will design and execute test plans for digital apps, data pipelines, and device interoperability, and manage defects in Azure DevOps, ensuring FDA/IEC 62304 and ISO 13485 alignment.

Qualifications

• Bachelor's or higher in Engineering or related field.
• Experience in software testing and test automation within regulated environments.
• Familiarity with FDA/IEC frameworks and ISO standards is a plus.

Responsibilities

• Lead software test design and execution for IHFM products.
• Manage defects, traceability, and release readiness in Azure DevOps.
• Collaborate with cross-functional teams to ensure audit readiness.

Skills

Test automation

CI/CD

Selenium

API testing

Education

Bachelor's degree in Engineering

Master's degree in related field

Tools

Azure DevOps

GitHub Actions

Azure Pipelines

Job description

Edwards Lifesciences in Irvine, CA seeks a Director for Software Systems, Process & Delivery to lead the IHFM software and data product delivery. You will own release readiness, design controls, and audit readiness while collaborating across cross-functional teams.

You will design and execute test plans for digital apps, data pipelines, and device interoperability, and manage defects in Azure DevOps, ensuring FDA/IEC 62304 and ISO 13485 alignment.