Job description
Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology. Job Summary: Leading software test automation and validation strategy and accomplishing objectives through leading the work of direct reports who exercise significant latitude and independence. Oversees automated testing and medical-device software validation across complex Software, cloud, Hardware, edge computers, mobile, AI/ML, and medical-imaging systems to ensure regulatory compliance, requirements traceability, and product quality. How you will make an impact: Automation testing Strategy, Standards and Governance Defines and implements the testing tools, processes, mechanisms, documentation, and automation infrastructure required to deliver software test automation and validation for complex multi-deciplinary products, in accordance with company design procedures, regulatory requirements, and medical-device standards such as IEC 62304. Automation Team Leadership, Capability and Capacity Leads, mentors, develops, and manages the automation team and sub-contractors, including task assignment, progress tracking, and professional development. Owns team resources, capacity, priorities, performance expectations, and capability development to ensure the function can meet business and validation needs. Software Product Testing for Medical-Device Oversees software-product testing activities and processes across complex Software, cloud, Hardware, mobile, and internally developed SaaS environments, including AI/ML pipelines, 3D processing and visualization, DICOM data workflows, backend services, frontend applications, GPU-based edge-computing systems, mobile applications, and cloud services/APIs. Cross-Functional Validation Leadership and Senior Stakeholder Influence Collaborates with R&D, DevOps and QA to design, execute, and maintain tests aligned with software and hardware updates, debugging, and field issues. Ensures traceability between requirements, test cases, and validation results within regulated environments. Regulated Environment Test Evidence and Compliance Alignment Maintains validation discipline and test evidence aligned with company design procedures, regulatory requirements, medical-device standards, and traceability expectations in regulated environments. Supports reviews, investigations, and documentation needs relating to validation results, test irregularities, debugging, field issues, regulatory requirements, and medical-device standards. What you’ll need: Bachelor's Degree in Computer Science, Information Systems, Engineering, or related field 12+ years of relevant experience in software quality, software testing, test automation, validation, or regulated product development, including 6+ years leading automation, validation, or software quality teams. Experience working in Medical Device environment Solid understanding of test frameworks, CI/CD pipelines, and version-control systems. Strong frontend and backend automation experience. Fluent written and verbal English.
About Edwards Lifesciences
Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
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.
Contact Us
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