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)

📌 medical device system engineer eu mdr Remediation (Pune)
🏢 Idexcel
📍 Pune