- 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 o Hazard identificationo Design FMEA (dFMEA)o Use FMEA (uFMEA)o 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 field.• 610 years of experience in medical device development, with at least 4-5 years focused on risk management.
- Solid understanding of ISO 14971, IEC 60601, ISO 13485, and FDA Quality System requirements
- Experience with electromechanical systems and respiratory therapy devices is highly preferred.
- Strong analytical, documentation, and communication skills.

📌 Risk Management Specialist (Medical Devices) (Bengaluru)
🏢 Staffing Services
📍 Bengaluru