Software Test and Automation Engineer

Edwards Lifesciences•Irvine, CA

2d•Onsite

About The Position

The Software Test and Automation Engineer supports the Implantable Heart Failure Management (IHFM) product suite by designing and executing software test plans, protocols, and cases, and developing automated tests. The work spans digital ecosystem applications for mobile and web, an application platform using microservices, and a data platform with Databricks components and pipelines. The engineer develops and maintains UI, API, and data-pipeline automated tests and integrates them into CI/CD pipelines to expand regression coverage. Responsibilities include functional, regression, integration, verification, and validation testing, including testing external-system integrations such as EMR/EHR. The role also validates Bluetooth and Bluetooth Low Energy communications between medical peripherals or IoT devices and Android/iOS devices, as well as interactions between embedded firmware and physical hardware. Testing covers the connected-device workflow from medical device or peripheral through BLE, mobile application, API, and cloud microservices. The position maintains requirements-to-test traceability and design-control discipline, manages defects and test artifacts in Azure DevOps, and produces software test documentation that meets FDA, IEC 62304, and ISO 13485 expectations. The role is based in Irvine, California, and involves in-person collaboration with cross-functional teams.

Requirements

Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or a related scientific or technical field and at least 2 years of relevant industry experience, or a master’s degree or equivalent in a related field.
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, such as Selenium, Appium, or Python.
Experience integrating tests into CI/CD, such as GitLab CI, GitHub Actions, or Azure Pipelines.

Nice To Haves

Hands-on experience testing web, mobile (iOS and Android), API, cloud, data-pipeline, or connected-device software.
Experience with software lifecycle, requirements, defect, or test management tools such as Azure DevOps, Jira, Jama, Codebeamer, Helix ALM, or TestRail.
Experience in a regulated medical device or SaMD environment, including familiarity with FDA quality system requirements, IEC 62304, ISO 13485, or ISO 14971.
Experience with Bluetooth/BLE-connected devices, embedded firmware, medical peripherals, or hardware/software integration.
Strong analytical, problem-solving, documentation, communication, and interpersonal skills.
Ability to work effectively with cross-functional teams, manage competing priorities, and maintain strong attention to detail.
Exposure to EMR/EHR integrations or healthcare interoperability standards such as HL7 or FHIR.
Familiarity with software languages or platforms such as .NET, Java, Python, GoLang, Rust, Scala, or Databricks.
ISTQB, CSTE, or similar software testing certification.
Experience with mobile automation (Appium, Espresso) and/or API automation.
Exposure to cardiac, hemodynamic, or implantable device technologies.

Responsibilities

Design and execute software test plans, protocols, and cases for assigned features across the IHFM product suite.
Build and maintain automated tests for UI, API, and data-pipeline software, and integrate them into CI/CD pipelines.
Perform functional, regression, and integration testing, including integrations with external systems such as EMR/EHR.
Perform verification and validation under established design controls and maintain traceability from requirements through test execution and defect closure.
Manage software defects and test artifacts in Azure DevOps; work with developers to reproduce defects, identify root causes, and confirm fixes.
Produce software test documentation aligned with FDA, IEC 62304, and ISO 13485 expectations.
Validate Bluetooth and BLE communication and interoperability between medical peripherals or IoT devices and Android/iOS devices.
Validate interactions between embedded firmware and physical hardware components, including sensors, readers, communication interfaces, medical peripherals, and supporting hardware where applicable.
Perform integration testing across the connected-device workflow: medical device/peripheral, BLE, Android/iOS application, API, and cloud/microservices.