Design Assurance Engineer

We 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.

• Assess existing design inputs and outputs for clarity, completeness, and testability. Rewrite, decompose, and align requirements across system, subsystem, and component levels.

• Update or rebuild the Requirements Traceability Matrix (RTM) to ensure end‑to‑end, bi‑directional traceability from user needs through verification and validation evidence.
• Review and revise FMEA, Hazard Analysis, and ISO 14971 risk documentation. Ensure clear linkage between requirements, risk mitigations, and verification activities.

• Evaluate V&V protocols and reports for alignment with updated requirements. Revise or draft protocols, test methods, and acceptance criteria as needed.

• Update, organize, and compile design control documentation into a compliant DHF, ensuring proper version control and change management.

• Partner with R&D, Systems Engineering, Quality, and Regulatory teams to close requirement gaps, support design changes, and address audit findings.

• Provide weekly progress updates outlining completed work, risks, and remaining gaps related to FDA inspection readiness.

• Strong experience in medical device design controls and FDA remediation
• Hands‑on expertise with requirements, RTMs, risk management, and V&V
• Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971
• Ability to work in fast‑paced, documentation‑heavy environments
• Prior audit or inspection readiness experience strongly preferred

• Clear scope and deliverables
• Contract role ideal for seasoned quality professionals