Senior Software Test and Automation Engineer

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA seeks a Software Test Engineer to own test strategy and automation for IHFM products. You will design scalable frameworks, integrate testing into CI/CD, and ensure regulatory compliance across web, mobile and backend systems.

Lead end-to-end testing, drive defect triage, and mentor junior engineers while collaborating with R&D, NPI and QA teams in a fast-paced, regulated medical devices environment.

Qualifications

• Bachelor’s degree in a STEM field and 4+ years of experience, or advanced degrees.
• Hands-on experience with software testing and test automation.
• Strong understanding of test methodologies and lifecycle in regulated environments.
• Experience testing web, mobile, and backend/cloud systems.
• Onsite role based in Irvine, CA; relocation not provided; resides within 50 miles of Irvine.

Responsibilities

• Own test strategy and automation across IHFM ecosystem (mobile/web apps, cloud, data).
• Design scalable automation frameworks and integrate testing into CI/CD pipelines.
• Define test coverage and traceability; drive high-quality validation practices.
• Lead end-to-end and integration testing across applications and microservices.
• Drive defect triage, root-cause analysis, and overall software quality with cross-functional teams.
• Create and review test documentation in Azure DevOps for regulatory compliance.
• Provide input into architecture and risk assessments from a quality perspective.
• Lead development of test systems on standard platforms and support qualification activities.
• Mentor junior engineers and evolve testing and automation practices.

Skills

Software testing

Test automation

CI/CD pipelines

Regulated environments

Web testing

Mobile testing

Backend/cloud testing

Documentation

Education

Bachelor’s degree in STEM

Master’s degree in STEM

PhD

Tools

Azure DevOps

Appium

Databricks

REST APIs

Job description

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team, part of the AI, Product and Platforms organization, is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It is our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you’ll make an impact:

• Own the test strategy and automation approach for key product areas across the IHFM ecosystem, including mobile/web apps, cloud platforms, and data systems

• Design and build scalable, maintainable automation frameworks using a risk-based approach, and integrate testing into CI/CD pipelines

• Define test coverage, ensure requirements traceability, and drive high-quality validation practices

• Lead end-to-end and integration testing across applications, microservices, data platforms, and external systems (e.g., EMR/EHR integrations like HL7, FHIR)

• Drive defect triage, root-cause analysis, and overall software quality in partnership with cross-functional teams

• Create and review test documentation (plans, protocols, reports) in tools like Azure DevOps, ensuring compliance with regulatory standards (FDA, IEC, ISO)

• Provide input into architecture, design reviews, and risk assessments from a quality and test perspective

• Lead development of National Instruments-based test systems on the standard test platform, including identifying processes requiring validation, defining validation plans and acceptance criteria, and supporting qualification and validation activities to ensure regulatory compliance

• Serve as a technical SME for electronics testing by designing complex test infrastructure and product interface fixtures, reducing hardware dependency where possible, and partnering with R&D and NPI teams to translate requirements into software/system designs with early focus on manufacturability

• Mentor junior engineers and help evolve team testing and automation practices

What you’ll need (Required):

• Bachelor’s degree in a STEM field + 4 years of experience (or Master’s + 3 years, or PhD)

• Hands‑on experience with software testing and test automation, including owning testing for features or subsystems

• Strong understanding of test methodologies and the software development lifecycle in regulated environments

• Experience testing web (React/Angular), mobile (iOS/Android), and backend/cloud systems

• This is an onsite role based in Irvine, CA. Relocation assistance is not provided, and candidates must reside within a 50‑mile radius of Irvine to be considered.

What else we look for (Preferred):

• Experience building automation frameworks across UI, API, and data layers, integrated into CI/CD

• Strong experience testing microservices, APIs, and data pipelines (e.g., Databricks, Python/Scala)

• Background in end-to-end/system integration testing across connected platforms

• Familiarity with Azure DevOps (ADO) or similar tools for test management and traceability

• Experience in medical devices, SaMD, or regulated industries

• Understanding of regulatory standards (FDA 21 CFR 820, IEC 62304, ISO 13485, ISO 14971)

• Exposure to healthcare systems (EMR/EHR, HL7, FHIR)

• Experience with connected devices, IoT, or hardware/software integration (Bluetooth/BLE a plus)

• Hands‑on mobile automation experience (e.g., Appium)

• Strong collaboration, communication, and technical documentation skills

• Certifications such as ISTQB, CSTE, or ASQ

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.