Risk Management Specialist

1 week ago

Nashik, India Tata Elxsi Full time

Tata Elxsi is truly your home to a billion possibilities. We believe in opportunities for everyone to be bold and curious and seek to shape the future. Explore what's possible, discover what you love to do, and find accelerated paths for growth. At Tata Elxsi, you matter. Roles and Responsibilities: - Develop and maintain risk management plans, procedures, and frameworks in compliance with ISO 14971. - Ensure risk management activities align with FDA 21 CFR Part 820.30 and ISO 13485 design control requirements. - Lead comprehensive risk analysis and mitigation for - Hazard identification - Design FMEA (dFMEA) - Use FMEA (uFMEA) - Product risk analysis and control - Integrate risk controls into the design and development process to ensure safety and compliance. - Collaborate with design, clinical, regulatory, and quality teams to assess and mitigate risks throughout the product lifecycle. - Provide risk-related input during design reviews, change control boards, and technical discussions. - Create and maintain risk files, traceability matrices, and risk-benefit analyses. - Ensure compliance with IEC 60601, ISO 80601 and ISO 14971 standards for electromechanical and respiratory devices. - Maintain clear, audit-ready documentation of risk assessments and mitigation strategies. - Participate in internal and external audits, representing risk management documentation and processes. - Experience with requirements and traceability tools such as IBM DOORS and Windchill. Education & Skills preferred: - MTech / ME / BE / BTech in Biomedical, Electrical, Mechanical, Systems Engineering, or related - 6-10 years of experience in medical device development, with at least 4-5 years focused on risk management. - Strong understanding of ISO 14971, IEC 60601, ISO 13485, and FDA Quality System - Experience with electromechanical systems and respiratory therapy devices is highly preferred. - Strong analytical, documentation, and communication skills.

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