Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT.
Tata Elxsi’s Medical Device and Healthcare practice is ISO 13485 certified.

Job Description: Risk Manager – Medical Device New Product Development (NPD)
Role: Risk Manager / Product Safety & Risk Management Lead
Experience: 10–15+ 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 New 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 protected 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

📌 Risk Manager – Medical Device NPD (Pune)
🏢 Tata Elxsi
📍 Pune