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 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.
• Strong 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.