Design Assurance Engineer

Contract Design Quality EngineerWe are seeking experienced Design Quality Engineers (Contract) to support design control activities in preparation for inspection readiness. This role focuses on strengthening requirements, traceability, risk management, and V&V documentation within regulated medical device development.What You’ll DoRequirements Review & CleanupAssess existing design inputs and outputs for clarity, completeness, and testability. Rewrite, decompose, and align requirements across system, subsystem, and component levels.Requirements TraceabilityUpdate or rebuild the Requirements Traceability Matrix (RTM) to ensure end‑to‑end, bi‑directional traceability from user needs through verification and validation evidence.Risk Management UpdatesReview and revise FMEA, Hazard Analysis, and ISO 14971 risk documentation. Ensure clear linkage between requirements, risk mitigations, and verification activities.Verification & Validation AlignmentEvaluate V&V protocols and reports for alignment with updated requirements. Revise or draft protocols, test methods, and acceptance criteria as needed.Design History File (DHF) RemediationUpdate, organize, and compile design control documentation into a compliant DHF, ensuring proper version control and change management.Cross‑Functional CollaborationPartner with R&D, Systems Engineering, Quality, and Regulatory teams to close requirement gaps, support design changes, and address audit findings.Status ReportingProvide weekly progress updates outlining completed work, risks, and remaining gaps related to FDA inspection readiness.What We’re Looking ForStrong experience in medical device design controls and FDA remediationHands‑on expertise with requirements, RTMs, risk management, and V&VWorking knowledge of 21 CFR 820, ISO 13485, and ISO 14971Ability to work in fast‑paced, documentation‑heavy environmentsPrior audit or inspection readiness experience strongly preferredWhy This RoleClear scope and deliverablesHigh‑impact remediation workCollaborative cross‑functional environmentContract role ideal for seasoned quality professionals