Test Engineer – Medical Devices & AI (Remote)

Job Description: Test Engineer – Medical Devices & AI

Experience Level: 5–8 Years

Department: Product, Data and AI Engineering

We are seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology (MedTech) and Artificial Intelligence (AI) to join our dynamic team. This role is critical in ensuring the safety, reliability, and compliance of AI-powered medical devices and Software as a Medical Device (SaMD) solutions.

•            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.