mlHealth 360
Website:
mlhealth360.com
Job details:
Role Description
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
Click on Apply to know more.