Senior Software Test and Automation Engineer

Edwards Lifesciences Gruppe; Alton (IL); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences is seeking a QA/Test Engineer for an onsite Irvine, CA role within the Implantable Heart Failure Management team. You will own test strategy and automation across mobile, web, cloud, and data platforms, ensuring traceability and regulatory compliance.

You’ll drive end-to-end testing, contribute to CI/CD pipelines, and mentor junior engineers while collaborating with R&D, NPI, and manufacturing teams to deliver robust SaMD-enabled solutions.

Qualifications

• Bachelor's degree in a STEM field with 4+ years experience, or Master’s with 3+ years, or PhD.
• Hands-on software testing and test automation ownership across features or subsystems.
• Strong understanding of SDLC in regulated environments (FDA IEC ISO).
• Experience testing web, mobile, and backend/cloud systems.
• This is an onsite Irvine, CA role; relocation not provided; within 50 miles.

Responsibilities

• Own the test strategy and automation approach for key product areas in IHFM ecosystem.
• Design scalable automation frameworks and integrate testing into CI/CD pipelines.
• Define test coverage, traceability, and high-quality validation practices.
• Lead end-to-end and integration testing across applications and data systems.
• Drive defect triage, root-cause analysis, and overall software quality with cross-functional teams.
• Create test documentation (plans, protocols, reports) with regulatory compliance in mind.
• Support architecture reviews and risk assessments from a testing perspective.

Skills

Test automation

Regulated environments

Web testing

Mobile testing

Backend testing

Documentation

Education

STEM degree (B.S. or higher)

Master’s degree preferred

PhD considered

Tools

Azure DevOps

Databricks

Python

Scala

Appium

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

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).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.