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USA - California – Irvine, United States of America
Onsite
Not Available
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
Must be based within 50 miles of Irvine, CA (no relocation support available)
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
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 $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.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.