Risk Manager – Medical Device New Product Development

About Tata Elxsi

Tata Elxsi partners with prominent medical device original equipment manufacturers and technology firms, providing services in market research, human factors engineering, hardware and software design, verification and validation, regulatory compliance, and cutting-edge technologies such as artificial intelligence, cloud solutions, and IoT. The Medical Device and Healthcare division is certified to ISO 13485 standards.

Role Overview

We are looking for a seasoned Risk Manager to oversee comprehensive risk management activities throughout the entire lifecycle of New Product Development (NPD) programs in the medical device sector. This leadership role demands the establishment and implementation of risk management processes aligned with regulatory mandates and standards.

Key Responsibilities

• Lead all risk management processes from concept through product commercialization.
• Develop and sustain Risk Management Plans that comply with project and regulatory requirements.
• Ensure adherence to standards such as ISO 14971, IEC 62304, ISO 13485, IEC 60601 series, IEC 62366, and FDA risk management expectations.
• Create and maintain risk management methodologies, documentation templates, and procedures.
• Drive detailed hazard identification activities covering hardware, firmware, software, mechanical systems, electrical systems, user interfaces, cybersecurity, and manufacturing processes.
• Facilitate analyses including hazard analysis, hazardous situation analysis, harm identification, use error analysis, and system-level risk evaluation.
• Maintain traceability connecting hazards, hazardous situations, harms, mitigation measures, and verification evidence.
• Conduct both quantitative and qualitative risk assessments considering severity and probability.
• Evaluate residual risks and overall product safety profile.
• Perform benefit-risk assessments where applicable and support organizational risk acceptance decisions.

Experience & Qualifications

• Between 10 to 15+ years in medical device product development.
• At least 5 years dedicated experience in Product Risk Management, Safety Engineering, or Reliability Engineering.
• Demonstrated leadership in New Product Development projects from inception to market launch.
• Extensive experience in managing cross-functional risk activities for complex medical devices.

Collaboration

This role requires close collaboration with multiple teams including Systems Engineering, Research and Development, Verification and Validation, Quality Assurance, Regulatory Affairs, Clinical, Cybersecurity, Manufacturing, and Program Management to ensure safe, compliant product development processes.

Contact

Interested candidates may reach out via sonali.p3@tataelxsi.co.in.