Many structural heart patients experience heart failure with limited treatment options. The Implantable Heart Failure Management (IHFM) team, part of the AI, Product and Platforms organization at Edwards Lifesciences, is focused on addressing these unmet needs through pioneering technology that enables earlier, more targeted therapeutic intervention. Our work helps clinicians deliver better care and supports patients in living longer, healthier lives.
As Director, Software Systems, Process & Delivery, you will lead the sub-function responsible for how IHFM's regulated software and data products are planned, documented, orchestrated, and delivered. Through managers and senior individual contributors, you will own delivery execution, release readiness, process and traceability systems, and design control discipline that keeps products audit-ready and aligned to patient, clinician, quality, and regulatory needs.
Based in Irvine, California, this role is part of a high-impact medtech innovation hub in Orange County, where you will collaborate in person with cross-functional teams to shape patient-focused technology.
How you'll make an impact
- Design and execute software test plans, protocols, and cases, and build the corresponding automated tests, for assigned features across the IHFM product suite: digital ecosystem applications (mobile and web), the application platform (microservices in .NET Core, Java, Python, GoLang, Rust), and the data platform (Databricks components and pipelines in Python, Scala).
- Develop and maintain automated tests (UI, API, and data-pipeline) and integrate them into CI/CD pipelines to grow reliable regression coverage.
- Perform functional, regression, and integration testing, including integrations with external systems such as EMR/EHR.
- Perform verification and validation (V&V) under established design controls, maintaining traceability from requirements through execution and defect closure.
- Manage software defects and software test artifacts in Azure DevOps (ADO); partner with developers to reproduce, root-cause, and confirm fixes.
- Produce software test documentation that meets FDA, IEC 62304, and ISO 13485 expectations and withstands audit scrutiny.
- Validate communication and interoperability between medical peripherals or IoT devices and Android/iOS devices using Bluetooth and Bluetooth Low Energy (BLE).
- 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 complete connected-device workflow: Medical Device/Peripheral, BLE, Android/iOS Application, API, Cloud/Microservices.
What you'll need (Required)
- Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related scientific/technical field with 2+ years of relevant industry experience -or-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 (e.g., Selenium, Appium, Python) and experience integrating tests into CI/CD (e.g., GitLab CI, GitHub Actions, Azure Pipelines).
What else we look for (Preferred)
- Hands-on experience testing web (Angular, React), 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 working 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.
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 $87,000 to $123,000 (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.