Test Engineer – Medical Devices & AI

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

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.

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.