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Software Test Automation and Validation Lead
On-siteFull-timeQA & Test AutomationMedical Devices
Lead software test automation and validation for complex regulated medical-device products spanning cloud, hardware, edge computing, mobile, AI/ML, medical imaging, and SaaS environments. Own testing strategy, team capacity, compliance evidence, and requirements traceability.
Responsibilities
- Define and implement testing tools, processes, standards, documentation, and automation infrastructure for complex multidisciplinary products.
- Lead, mentor, develop, and manage the automation team and subcontractors, including assignments, progress tracking, performance expectations, and professional development.
- Own team resources, capacity, priorities, and capability development.
- Oversee software-product testing across cloud, hardware, mobile, AI/ML pipelines, 3D processing, DICOM workflows, backend services, frontend applications, GPU-based edge systems, and APIs.
- Collaborate with R&D, DevOps, and QA to maintain tests aligned with software and hardware updates, debugging, and field issues.
- Ensure traceability between requirements, test cases, and validation results.
- Maintain test evidence and validation discipline in line with design procedures, regulatory requirements, and medical-device standards including IEC 62304.
- Support reviews, investigations, and documentation related to validation results, test irregularities, field issues, and compliance requirements.
Requirements
- Bachelor’s degree in Computer Science, Information Systems, Engineering, or a related field.
- At least 12 years of relevant experience in software quality, software testing, test automation, validation, or regulated product development.
- At least 6 years leading automation, validation, or software quality teams.
- Experience in a medical-device environment.
- Strong knowledge of test frameworks, CI/CD pipelines, and version-control systems.
- Strong frontend and backend automation experience.
- Fluent written and verbal English.