Risk Manager Medical Device NPD

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 Elxsis Medical Device and Healthcare practice is ISO 13485 certified.

: 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 safe 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, mitigations, and verification evidence.

Risk Assessment & Evaluation

• Perform quantitative and qualitative risk assessments.
• Facilitate severity and probability assessments.
• Evaluate residual and overall product risks.
• Conduct benefit-risk analyses where applicable.
• Support risk acceptance decisions based on organizational criteria.

[HIDDEN TEXT]

Experience

• 10–15+ years of experience in medical device product development.
• 5+ years in Product Risk Management, Safety Engineering, or Reliability Engineering roles.
• Proven experience in New Product Development (NPD) programs from concept through commercialization.
• Experience leading cross-functional risk management activities for complex medical devices.