Senior Software Test and Automation Engineer

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

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Software QA professional to own test strategy and automation for the IHFM ecosystem, spanning mobile/web apps, cloud platforms, and data systems.

You will design scalable automation frameworks, drive end-to-end testing across microservices and external systems, and ensure compliance with FDA/IEC/ISO. Onsite role with relocation not provided; strong collaboration across R&D and QA teams is essential.

Qualifications

• Bachelor's degree in a STEM field required.
• 4+ years of experience in software testing and automation in regulated environments.
• Experience testing web/mobile/backend/cloud systems.

Responsibilities

• Own test strategy and automation for IHFM ecosystem.
• Design and build scalable automation frameworks and integrate with CI/CD.
• Define test coverage and requirements traceability; drive high-quality validation.
• Lead end-to-end and integration testing across applications, microservices, data platforms.
• Create and review test documentation in Azure DevOps; ensure regulatory compliance.
• Contribute to architecture and risk assessments from a quality perspective.
• Lead development of NI-based test systems and validate accordingly.
• Mentor junior engineers and evolve testing practices.

Skills

Test automation

CI/CD

Web/mobile testing

Documentation

Regulated environments

Education

Bachelor's degree in STEM

Tools

Azure DevOps

Appium

Databricks

Python/Scala

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 systemsDesign and build scalable, maintainable automation frameworks using a risk-based approach, and integrate testing into CI/CD pipelinesDefine test coverage, ensure requirements traceability, and drive high-quality validation practicesLead 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 teamsCreate 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 perspectiveLead 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 complianceServe 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 manufacturabilityMentor junior engineers and help evolve team testing and automation practicesWhat 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 subsystemsStrong understanding of test methodologies and the software development lifecycle in regulated environmentsExperience testing web (React/Angular), mobile (iOS/Android), and backend/cloud systemsThis 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/CDStrong experience testing microservices, APIs, and data pipelines (e.g., Databricks, Python/Scala)Background in end-to-end/system integration testing across connected platformsFamiliarity with Azure DevOps (ADO) or similar tools for test management and traceabilityExperience in medical devices, SaMD, or regulated industriesUnderstanding 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 skillsCertifications such as ISTQB, CSTE, or ASQAligning 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.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.