Job Summary:

We are seeking an experienced Risk Management Engineer to support medical device product development and remediation activities by ensuring product risks are appropriately identified, evaluated, documented, and mitigated throughout the product lifecycle. The ideal candidate will have strong expertise in ISO 14971, risk analysis, design controls, and regulatory compliance within a regulated medical device environment.

Key Responsibilities:

- Provide risk management expertise across product development and remediation projects.

- Review design documentation to ensure appropriate risk identification and mitigation.

- Support hazard analysis, risk assessments, and risk management file updates.

- Develop risk-based justifications to address documentation gaps.

- Ensure traceability between hazards, risk controls, design requirements, and verification activities.

- Collaborate with Engineering, Quality, Regulatory, Clinical, Manufacturing, and V&V; teams.

- Identify risk management gaps and recommend corrective actions.

- Support design control activities, regulatory inspections, audits,



and compliance initiatives.

Required Qualifications:

- Bachelor's degree in Engineering, Biomedical Engineering, or a related technical discipline.

- 10+ years of experience in medical device risk management.

- Solid knowledge of ISO 14971, FDA Quality System Regulations, and medical device design controls.

- Experience with hazard analysis, risk assessments, risk controls, and residual risk evaluation.

- Experience supporting remediation projects in regulated environments.

- Strong technical writing, documentation review, and cross-functional collaboration skills.

Preferred Qualifications:

- Experience with FMEA, Fault Tree Analysis (FTA), use-related risk analysis, and benefit-risk analysis.

- Experience supporting Design Controls remediation and risk traceability.

- Familiarity with ISO 13485, IEC 62304, IEC 62366, and other applicable medical device standards.

- Experience supporting regulatory inspections and quality audits.

📌 Risk Management Engineer (Hyderabad)
🏢 Intellectt
📍 Hyderabad