System Engineer

Role Summary: 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.

Key Responsibilities

• Perform DHF and Technical Documentation gap assessments against EU MDR 2017/745 requirements.
• Review and remediate User Needs, Intended Use, System Requirements, Design Inputs and Design Outputs.
• Create and maintain requirements traceability matrices linking requirements, risks, verification and validation evidence.
• Support remediation of Technical Documentation as per MDR Annex II and Annex III.
• Lead risk management activities including Hazard Analysis, FMEA, FTA and benefit-risk assessments.
• Participate in Design Reviews, Change Control and CAPA activities.
• Support Notified Body observations and remediation responses.
• Coordinate with Regulatory Affairs, Quality Assurance, Mechanical, Software and V&V teams.
• Support creation and review of Clinical Evaluation, PMS and PMCF related technical inputs where required.

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
• Medical Device Product Development Lifecycle