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.
Skills Required
- Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or a related scientific or technical field with 2+ years of relevant industry experience, or a Master's degree or equivalent in a related field.
- Experience in software testing 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 programming language, such as Selenium, Appium, or Python.
- Experience integrating automated tests into CI/CD systems, such as GitLab CI, GitHub Actions, or Azure Pipelines.
- Hands-on experience testing web, mobile, 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 Software as a Medical Device environment, including FDA quality system requirements, IEC 62304, ISO 13485, or ISO 14971.
- Experience with Bluetooth or BLE-connected devices, embedded firmware, medical peripherals, or hardware/software integration.
- Exposure to EMR/EHR integrations or healthcare interoperability standards such as HL7 or FHIR.
- Familiarity with .NET, Java, Python, GoLang, Rust, Scala, or Databricks.
- ISTQB, CSTE, or similar software testing certification.
- Experience with mobile automation using Appium or Espresso and/or API automation.
- Exposure to cardiac, hemodynamic, or implantable device technologies.
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Healthcare Strength — Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
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Retirement Support — A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
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Equity Value & Accessibility — An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
