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 advantage-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

Regulatory Knowledge

• EU MDR 2017/745

• ISO 13485

• ISO 14971

• FDA 21 CFR Part 820 / QMSR

• IEC 62366 Usability Engineering

• IEC 60601 series (preferred)

Tools and Platforms

• Windchill, Agile PLM, Teamcenter, Microsoft Office

Preferred Experience

• Patient Monitoring Systems

• Imaging Devices

• Infusion Systems

• Cardiovascular Devices

• Surgical Devices

• Ventilators and Respiratory Devices

• Class II and Class III Medical Devices

Soft Skills

• Solid communication and stakeholder management

• Analytical problem-solving capabilities

• Ability to work with global cross-functional teams

• Experience leading technical reviews and workshops

📌 System Engineer Maharashtra
🏢 Glauben Technologies
📍 Maharashtra