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 h 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.Strong 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 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.
4 days ago