Product Manager

As a Product Manager at mlHealth 360, you will lead the next phase of development for our AI-driven Radiology solutions, including medical imaging diagnostic AI products. The ideal candidate will combine technical acumen, clinical understanding, and regulatory awareness to drive end-to-end product lifecycle — from concept to deployment and compliance with Indian SaMD regulations. Key Responsibilities 1. Product Strategy & Roadmap • Define and own the product roadmap for AI-based radiology applications in CT, MRI, and X-ray domains. • Conduct market and competitive analysis to identify gaps, unmet clinical needs, and differentiation opportunities. • Collaborate with leadership to align product goals with company vision and market strategy. 2. Product Development & Execution • Translate clinical and business requirements into actionable product specifications and user stories. • Work closely with AI/ML, software engineering, and UX teams to ensure timely, high-quality product releases. • Participate in sprint planning, backlog grooming, and product reviews. • Drive validation activities, including performance testing, reader studies, and usability testing. 3. Regulatory & Quality Compliance (SaMD) • Ensure product design and documentation comply with CDSCO, ISO 13485, IEC 62304, ISO 14971, and MDR (India) requirements for Software as a Medical Device. • Collaborate with QA/RA teams on: o Risk management files and traceability matrices. o Clinical evaluation and post-market surveillance plans. o Change control and version management procedures. • Support technical file preparation for CDSCO submission and other international markets (e.g., CE, FDA if applicable). 4. Stakeholder Engagement • Work closely with radiologists, clinicians, and hospital IT teams to capture feedback and validate clinical workflows. • Liaise with sales, marketing, and customer success teams to support pre-sales demos, training, and go-to-market launches. • Communicate product vision and performance to internal and external stakeholders. 5. Data, AI, and Platform Integration • Understand and evaluate AI model performance metrics, datasets, and annotation processes. • Collaborate with the AI team to define dataset requirements, validation protocols, and model integration pipelines. • Support deployment of cloud-based and PACS-integrated AI workflows (e.g., DICOM, HL7, FHIR) Required Skills and Qualifications: Education • Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related field. • Master’s in Healthcare Technology, Product Management, or Business Administration is a plus. Experience • 4–7 years of total experience, including 2+ years in product management (preferably in medical imaging, digital health, or SaMD). • Experience with AI-based medical imaging solutions, cloud/SaaS platforms, or clinical workflow systems preferred. • Working knowledge of Indian regulatory requirements for SaMD — CDSCO, ISO 13485, IEC 62304, and related frameworks. • Prior experience working with cross-functional R&D and clinical validation teams. Technical & Domain Skills • Understanding of CT/MRI modalities, DICOM standards, and PACS/RIS integration. • Familiarity with AI/ML lifecycle concepts — model training, testing, validation, and deployment. • Exposure to cloud platforms (AWS/Azure/GCP), APIs, and containerization (Docker/Kubernetes). • Proficiency with Agile tools (Jira, Confluence, Asana). Soft Skills • Strong analytical and problem-solving mindset. • Excellent communication and stakeholder management abilities. • Ability to translate complex clinical and technical concepts into clear product strategies. • Passion for improving healthcare outcomes through AI innovation