Job Description:
• Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data integrity, and performance under various clinical scenarios.
• Design and execute comprehensive white-box and black-box testing strategies for embedded systems, cloud-based platforms, and AI components.
• Apply knowledge of SaMD classification, regulatory frameworks (e.g., FDA, MDR), and quality processes to ensure product compliance and audit readiness.
• Lead and contribute to verification and validation (V&V) activities across the product lifecycle, ensuring traceability, risk mitigation, and adherence to design controls.
• Create and maintain high-quality test plans, protocols, reports, and defect logs aligned with regulatory and internal standards.
• Work closely with product managers, data scientists, software engineers, and quality teams to ensure alignment and transparency throughout the development cycle.
• Clearly articulate test results, risks, and recommendations to technical and non-technical stakeholders.
Requirements:
• Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.
• 5–8 years of experience in software testing, preferably in medical devices or healthcare technology.
• Strong understanding of AI/ML systems, including model validation and bias detection.
• Hands-on experience with white-box and black-box testing methodologies.
• Familiarity with SaMD regulations, ISO 13485, IEC 62304, and related standards.
• Proven track record in verification and validation of regulated software products.
• Excellent verbal and written communication skills.
• Experience with test automation tools and frameworks is a plus.
• Knowledge of risk management processes (ISO 14971).
• Experience with cloud platforms (AWS, Azure) and CI/CD pipelines.
• Familiarity with data privacy and cybersecurity standards in healthcare.
• Testing experience in surgery-related AI.
• Test data validation for computer vision and video-based AI.
Benefits:
• Remote Work Type: Full Time