About the role
Requirements:
- Required Technical Skills: Systems Engineering and Requirements Engineering, Design Controls and Design Assurance, DHF, DMR and Technical File remediation, Risk Management as per ISO 14971 Traceability Management, Change Control and CAPA, Root Cause Analysis.
- Experience in Medical Device Product Development Lifecycle.
- Know about Systems Engineering and Requirements Engineering, IEC 62366 Usability Engineering, Design Controls and Design Assurance, DHF, DMR and Technical File remediation, Risk Management as per ISO 14971 Traceability Management, Medical Device Product Development Lifecycle, EU MDR 2017/745 ISO 13485 ISO 14971 FDA 21 CFR Part 820 / QMSR.
- Good communication skills.