Domain Expert - MedTech AI & Digital Health Role overview Field Detail Job title Practice Lead - MedTech AI & Digital Health Role type Domain Expert Reporting to DU Head/Delivery Manager Focus Medical Imaging AI, SaMD, Clinical GenAI, Regulatory Compliance Role objective Lead the MedTech practice in building AI-enabled, regulation-ready medical devices and software, from imaging AI to agentic clinical and regulatory workflows. Key responsibilities

• Strategy: Define the MedTech AI roadmap across imaging, monitoring, and point-of-care devices.
• Tech hubs: Lead three hubs: Imaging & Computer Vision, Clinical GenAI & Regulatory Intelligence, and Connected Devices & Interoperability.
• Compliance: Embed IEC 62304, ISO 13485, ISO 14971, and GMLP into AI delivery; support FDA 510(k) and EU MDR submissions.
• Standards: Own the medical AI "Golden Stack" and MLOps practices for validation and traceability.
• Accelerators: Build reusable assets, such as regulatory compliance assistants and imaging AI components.
• Growth: Drive pre-sales solutioning, client advisory, and thought leadership.



Mandatory skills
• Experience: 15-20 years total; at least 8 years in MedTech, including 5+ in AI/ML architecture.
• Medical imaging and computer vision: Deep learning for medical images and video (PyTorch, OpenCV).
• Production AI deployment: Model optimization and edge inference (ONNX Runtime, TensorRT, OpenVINO).
• Regulatory knowledge: IEC 62304, ISO 13485, ISO 14971, FDA 510(k).
• Healthcare standards: DICOM, PACS.
• Generative AI: LLMs, RAG, and agentic AI in production.
• Leadership: Led multi-disciplinary AI teams and senior client stakeholders. Desired skills
• Clinical workflows: radiology, cardiology, obstetrics, ultrasound
• AI regulation: FDA AI/ML guidance, PCCP, EU MDR, EU AI Act, IEC 81001-5-1
• Interoperability: HL7 v2, FHIR, EHR integration
• MONAI, NVIDIA Clara/Holoscan, Orthanc
• Cloud healthcare services and MLOps (MLflow, Kubeflow)
• Publications, patents, or open-

📌 Solution Architect (Thiruvananthapuram)
🏢 NeST Digital
📍 Thiruvananthapuram