Test Engineer – Medical Devices & AI (Remote)

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