medical device system engineer eu mdr Remediation

Role & responsibilities

Position Name : Medical Device Systems Engineer EU MDR Remediation

Location: Pune

Qualification : Bachelor’s or master's degree in biomedical, Mechanical, Electronics, Systems Engineering or related

Domain Specific: Medical

Overall Experience: 8-15 Years

Relevant Experience: 8-15 Years

Mandatory Skills: Medical Device Product life cycle, CAPA, RCA, Traceability ,Risk management, ISO 14971,DHF, DMR, Remediation, Design control & assurance

Detailed JD

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
• Regulatory Knowledge
• EU MDR 2017/745
• ISO 13485
• ISO 14971
• FDA 21 CFR Part 820 / QMSR
• IEC 62366 Usability Engineering
• IEC 60601 series (preferred)