Job Description: Risk Manager – Medical Device Current Product Development (NPD)

Role: Risk Manager / Product Safety & Risk Management Lead
Experience: 10 to 15+ Years
Domain: Medical Devices / Healthcare Products / Safety-Critical Systems

Role Overview

We are seeking an experienced Risk Manager to lead and govern end-to-end product risk management activities for Medical Device Recent Product Development (NPD) programs. The role will be responsible for establishing and executing risk management processes across the entire product lifecycle, ensuring compliance with applicable standards and regulatory requirements.

The ideal candidate should have deep expertise in product safety, hazard analysis, risk assessment, reliability engineering, and cross-functional risk management involving hardware, firmware, software, systems engineering, cybersecurity, usability, manufacturing, and clinical domains.

This role will work closely with Systems Engineering, R&D;, V&V;, Quality, Regulatory, Clinical, Cybersecurity, Manufacturing,



and Program Management teams to ensure secure and compliant product development.

Key Responsibilities

Product Risk Management Leadership
Lead end-to-end risk management activities throughout the product lifecycle.
Establish and maintain Risk Management Plans aligned with project and regulatory requirements.
Ensure compliance with:
ISO 14971
IEC 62304
ISO 13485
IEC 60601 Series
IEC 62366
FDA Safety & Risk Management expectations
Define and implement risk management processes, procedures, and templates.

Hazard Identification & Analysis
Drive comprehensive hazard identification activities across:
Hardware
Firmware
Software
Mechanical Systems
Electrical Systems
User Interfaces
Cybersecurity
Manufacturing Processes
Facilitate:
Hazard Analysis
Hazardous Situation Analysis
Harm Identification
Use Error Analysis
System-Level Risk Analysis
Establish traceability between hazards, hazardous situations, harms, miti

📌 Risk Manager Bengaluru
🏢 Tata Elxsi
📍 Bengaluru