Senior Software (Quality Engineer 4) - CoE structure
Intuitive Surgical
Intuitive Surgical seeks a Senior Software Quality Engineer to provide independent technical quality oversight for software-based medical devices, digital health solutions, and AI/ML-enabled products. This role partners with engineering teams to drive quality-by-design practices throughout the software development lifecycle while maintaining regulatory compliance and objective quality judgment.
Responsibilities
- Serve as independent quality authority and technical partner across software development lifecycle activities
- Participate in architecture, design, and technical reviews to identify quality, reliability, and cybersecurity risks early
- Assess software lifecycle execution against regulatory standards and organizational quality procedures
- Evaluate DevOps practices, CI/CD pipelines, release readiness, and software configuration management
- Support AI/ML and digital health product quality oversight including data quality, model validation, and bias assessment
Requirements
- Strong software engineering knowledge and deep understanding of modern SDLC practices
- Experience with IEC 62304, FDA Quality System requirements, and ISO 13485 standards
- Proficiency in software architecture review, design assessment, and risk-based quality evaluation
- Familiarity with Agile, DevOps, CI/CD, and iterative development methodologies
- Knowledge of cybersecurity frameworks (NIST, FDA guidance) and secure development practices
- Experience with AI/ML quality oversight and regulatory considerations for healthcare products
Vacancy posted 7 days ago
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