Job Description: Test Engineer – Medical Devices & AI
Experience Level: 5–8 Years
Department: Product, Data and AI Engineering
About the Role:
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.
Key Responsibilities:
• 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.
Required Qualifications:
• 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.
• Solid 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, a

📌 Test Engineer – Medical Devices (Pune)
🏢 Codvo.ai
📍 Pune