Test Engineer – Medical Devices & AI

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 Apply tot his job Apply To this Job