Technical Product Manager (Medical Domain)
Location: ClayWorks Shankaraa, Doddakallasandra, Bengaluru
Experience Required: 4 – 7 Years
Company: Drongo AI Pvt Ltd
About Us
Drongo AI is a technology enterprise building intelligent software solutions across healthcare, industrial automation, AI, and enterprise applications. We focus on developing scalable products that solve real-world problems through modern engineering practices.
Job Summary
Role Overview
Drongo is seeking a highly technical, systems-oriented Technical Product Manager (TPM) to bridge the gap between clinical intent, complex software engineering, and medical regulatory standards. In this role, you will take ownership of our core platform technology, converting complex healthcare workflows and user needs into actionable technical specifications, system architecture inputs, and execution backlogs.
You will work at the intersection of engineering, regulatory affairs, quality management, and clinical usability to ship secure, reliable, and compliant digital health and medical software solutions (Software as a Medical Device - SaMD).
Key Responsibilities
1. Technical Requirements & Backlog Ownership
- Requirement Translation: Translate high-level clinical, operational, and user needs into detailed Software Requirements Specifications (SRS), functional specs, and engineering epics.
- Backlog Management: Maintain and prioritize the technical product backlog, ensuring clear acceptance criteria, API definitions, data models, and system edge cases are fully defined for engineering sprints.
- Architecture Collaboration: Partner with lead architects and software engineers to evaluate trade-offs between system performance, technical debt, build-vs-buy components, and regulatory impact.
2. Regulatory Compliance & Quality System Alignment
- Medical Software Standards: Ensure all product features align with IEC 62304 (Medical Device Software Lifecycle), ISO 13485 (QMS), and ISO 14971 (Application of Risk Management to Medical Devices).
- Traceability Matrix: Maintain rigorous design control documentation, managing the traceability matrix linking user needs to software requirements, architectural components, and verification/validation (V&V) test cases.
- Risk Control Implementation: Collaborate with regulatory and QA teams to translate risk analysis outputs (hazards, failure modes) into active software mitigations and safety boundaries.
3. Data Protocols, Security & Integrations
- Healthcare Interoperability: Architect integration specifications for standard healthcare protocols (e.g., HL7, FHIR, DICOM) and Electronic Health Record (EHR/EMR) systems.
- Data Security & Privacy: Enforce strict compliance with HIPAA, GDPR, and local health data governance frameworks regarding data encryption, access controls, audit logging, and cloud infrastructure security.
4. Cross-Functional Execution & Release Delivery
- Agile Sprint Delivery: Drive technical sprint planning, grooming, and technical review meetings with cross-functional engineering teams (frontend, backend, AI/ML, cloud infrastructure).
- Release Verification: Participate in formal release reviews, ensuring technical documentation, test summary reports, and anomaly evaluations are complete prior to product deployments.
Requirements & Qualifications
- Experience: 4 to 7 years of hands-on experience as a Technical Product Manager, or Product Owner, in the Medical Device, Healthtech, Life Sciences, or SaMD space.
- Technical Background: Bachelor’s degree in Computer Science, Biomedical Engineering, Electrical Engineering, or a related technical discipline.
- Regulatory Knowledge: Direct experience working within regulated software design controls (IEC 62304, ISO 13485, FDA 21 CFR Part 820, or CE/MDR requirements).
- Protocol & Systems Knowledge: Understanding of health data integration standards (FHIR/HL7) and cloud-based architecture designs.
- Tooling Proficiency: Deep familiarity with Jira, Confluence, design control software/RIMS, and API documentation tools (e.g., Postman, Swagger/OpenAPI).
Preferred Qualifications
- Prior software development or systems engineering experience before transitioning into technical product management.
- Experience with AI/ML algorithm lifecycle management or medical imaging workflows in a regulated clinical setup.
- Certified Scrum Product Owner (CSPO) or Pragmatic Institute certifications.
Pay: From ₹1,400,000.00 per year
Benefits:
- Provident Fund
- Work from home
Application Question(s):
- Do you have technical product management in the Medical Domain?
Experience:
- total: 4 years (Required)
Work Location: In person