Risk Manager - Medical Devices

Tata Elxsi; Pune District, Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Tata Elxsi in Pune, India is seeking an experienced Risk Manager to lead end-to-end product risk management for Medical Device NPD programs, ensuring compliance with ISO 14971, IEC 62304, and other standards.

The role requires deep expertise in hazard analysis, risk assessment, reliability, and cross-functional risk governance across hardware, firmware, software, cybersecurity, usability, manufacturing, and clinical domains.

Qualifications

• Must have strong expertise in ISO 14971 risk management and medical device safety.
• Experience with hazard analysis, harm analysis, and risk assessment across hardware, firmware, software and systems.
• Proven ability to lead cross-functional risk management for complex medical devices.
• Experience supporting regulatory submissions and audits is preferred.

Responsibilities

• Lead end-to-end risk management activities across 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 and FDA expectations.
• Define and implement risk management processes, procedures, and templates.
• Drive hazard identification across hardware, firmware, software, mechanical and electrical systems, cybersecurity, usability, and manufacturing.
• Facilitate Hazard Analysis, Hazardous Situation Analysis, Harm Identification, Use Error Analysis, and System-Level Risk Analysis.
• Establish traceability between hazards, harms, mitigations and verification evidence.
• Perform quantitative and qualitative risk assessments; evaluate residual and overall risks; conduct benefit-risk analyses.
• Support risk acceptance decisions within organizational policies.

Skills

ISO 14971 Risk Management for Medical

Safety Engineering

Product Risk Management

Reliability Engineering

Human Factors Engineering

Systems Engineering

Hazard Analysis

Harm Analysis

FMEA (DFMEA, PFMEA, SFMEA)

Fault Tree Analysis (FTA)

Risk-Benefit Analysis

Job description

Job Description: Risk Manager – Medical Device New 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 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 analysis where applicable.
• Support risk acceptance decisions based on organisational…

Must-Have Skills

• Strong expertise in ISO 14971 Risk Management for Medical Devices
• Deep understanding of:
  • Safety Engineering
  • Product Risk Management
  • Reliability Engineering
  • Human Factors Engineering
  • Systems Engineering
• Experience performing:
  • Hazard Analysis
  • Harm Analysis
  • FMEA (DFMEA, PFMEA, SFMEA)
  • Fault Tree Analysis (FTA)
  • Reliability Assessments
  • Risk-Benefit Analysis
• Experience working with:
  • Hardware Systems
  • Embedded Firmware
  • Software Applications
  • Integrated Medical Device Systems
• Strong understanding of medical device development lifecycle and design controls.
• Experience supporting regulatory submissions and audits.
• Excellent facilitation, stakeholder management, and communication skills.

Experience

• 10 to 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.