Test Engineer Medical Devices & AI

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.