Position: Risk Management Engineer

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 requires strong expertise in medical-device risk management, with alignment to
FDA QMSR and ISO 14971
.

Key Responsibilities:
- Provide risk-management expertise across remediation workstreams.
- Review design documentation for appropriate consideration of product risk.
- Support retrospective risk evaluations and documentation remediation.
- Develop risk-based justifications for documentation gaps.
- Support risk-management-file updates, hazard analyses, risk assessments, and risk-control traceability.
- Review user needs, product requirements, design inputs/outputs, V&V; documentation, and design-transfer records.
- Identify risk-management gaps and recommend remediation actions.
- Ensure risk controls are properly verified and linked to design and testing documentation.
- Collaborate with Engineering, Quality, Regulatory, Clinical,



Manufacturing, and V&V; teams.
- Support regulatory inspections, audits, and remediation activities.

Required Qualifications:
- 15+ years of experience in risk management within medical-device development is a must.
- Experience supporting remediation initiatives in regulated environments.
- Strong knowledge of
ISO 14971
and medical-device risk-management principles.
- Familiarity with
FDA QMSR
and global regulatory requirements.
- Experience reviewing design documentation and Design Controls.
- Solid understanding of hazard analysis, risk assessment, risk controls, and residual-risk evaluation.
- Excellent technical writing and documentation-review skills.

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

📌 Risk Management Engineer (Hyderabad)
🏢 Intellectt
📍 Hyderabad