Job Summary The Risk Management Engineer will support remediation workstreams by ensuring appropriate consideration of product risk throughout retrospective design reviews and documentation updates.

The role will provide risk-management expertise to ensure alignment with applicable risk-management expectations under FDA Quality Management System Regulation and ISO 14971.

Key Responsibilities

- Provide risk-management expertise across remediation workstreams.
- Review design documentation to ensure appropriate consideration of product risk.
- Support retrospective evaluation of risk within design documentation.
- Assist in the development of risk-based justifications where documentation gaps exist.
- Ensure risk considerations are incorporated during documentation updates and remediation activities.
- Provide guidance on alignment with risk-management expectations under FDA QMSR and ISO 14971.
- Collaborate with cross-functional teams to ensure risk perspectives are appropriately integrated.
- Review user needs, product requirements, design inputs, design outputs, V&V; documentation, and design-transfer records for risk considerations.
- Support risk-management-file updates, hazard analyses, risk assessments, and risk-control traceability.
- Identify risk-management gaps and provide remediation recommendations.




- Ensure risk controls are appropriately verified and linked to applicable design and testing documentation.
- Support regulatory inspections, audits, and remediation-program activities.

Required Qualifications
- 10+ years of experience in risk management within medical-device development.
- Experience supporting remediation initiatives within regulated environments.
- Familiarity with risk-management principles and methodologies.
- Experience applying or reviewing risk processes aligned with ISO 14971.
- Familiarity with risk-management expectations under FDA QMSR and global regulatory frameworks.
- Experience reviewing design documentation with risk considerations.
- Strong understanding of hazard analysis, risk assessment, risk controls, and residual-risk evaluation.
- Solid technical-writing and documentation-review skills.
- Ability to work with Engineering, Quality, Regulatory, Clinical, Manufacturing, and V&V; teams.

Preferred Qualifications
- Experience with FMEA, FTA, use-related risk analysis, and benefit-risk analysis.
- Experience supporting Design Controls remediation.
- Experience establishing traceability between hazards, risk controls, design requirements, and verification activities.
- Familiarity with ISO 13485, IEC 62304, IEC 62366, and applicable medical-device standards.
- Experience supporting FDA inspections or Notified Body audits.

📌 Risk Management Engineer (Chennai)
🏢 Tekone It Services
📍 Chennai