System Engineer Medical Device (Contract)
Job Summary
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.