Solution Architect - MedTech AI

Nest Digital; Thiruvananthapuram; On-site; INR 4,000,000 - 8,000,000; Full time

Job summary

Nest Digital is seeking a Practice Lead for MedTech AI & Digital Health to lead an AI-enabled, regulatory-ready medical devices and software initiative, spanning imaging AI to clinician workflows.

The role oversees practice leadership, regulatory integration, and multi-disciplinary teams to deliver compliant AI solutions in medical imaging, monitoring, and point-of-care devices.

Qualifications

• 15-20 years total experience with at least 8 years in MedTech, plus 5+ years in AI/ML architecture.
• Medical imaging and computer vision experience: DL for medical images/videos (PyTorch, OpenCV).
• Regulatory knowledge: IEC 62304, ISO 13485, ISO 14971, FDA 510(k) familiarity.
• Healthcare interoperability: DICOM, PACS; Generative AI in production (LLMs, RAG, agentic AI).

Responsibilities

• Define the MedTech AI roadmap across imaging, monitoring, and point-of-care devices.
• Lead three tech hubs: Imaging/Computer Vision; Clinical GenAI & Regulatory Intelligence; Interoperability.
• Embed IEC 62304, ISO 13485, ISO 14971 and GMLP into AI delivery; support FDA/EU regulatory submissions.
• Own the medical AI 'Golden Stack' and MLOps for validation and traceability.
• Build reusable assets like regulatory compliance assistants and imaging AI components.
• Drive pre-sales support, client advisory, and thought leadership.

Job description

Job Summary

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-source work in medical AI

Tech stack expectations

• Area Technologies: Imaging AI PyTorch, MONAI, YOLO, MedSAM
• Inference: ONNX Runtime, TensorRT, OpenVINO
• GenAI: Llama, Mistral, GPT, Gemini, Claude; LangChain/LangGraph; vector DBs
• Platform: Python, C++, FastAPI, Docker, Kubernetes

Education and qualifications

Degree or diploma in CS, IT, Electronics, or related field, or equivalent experience.