System Engineer - Medical Device (Contract)

Mandatory Skills System engineer, DHF Remediation, Gap assessment, V-model, Requirements trace matrix, Requirements drafting, DFMEA

Role Overview:

The Systems Engineer will support EU MDR 2017/745 remediation programs for Class I, II and III medical devices. The role involves gap assessment, design control remediation, requirements engineering, traceability management, risk management, technical documentation updates, and cross-functional collaboration to ensure compliance with EU MDR, ISO 13485, ISO 14971 and applicable product standards.