Job highlights

- Qualifications: Bachelor s or masters degree in biomedical,Mechanical,Electronics,Systems Engineering or related . Disclaimer: This job posting has been aggregated from external source
- Experience with CAPA,RCA,and Traceability
- Experience in Risk Management and application of ISO 14971
- Experience with DHF,DMR,and remediation activities

Position Name:Medical Device Systems Engineer - EU MDR Remediation

Location:Pune

Experience: 8-15 years

About BinQle

BinQle is a global delivery and execution partner supporting enterprises across the US, India, Singapore and Australia. We specialize in structured hiring, managed teams, and long-term delivery support.

Role Summary

The Systems Engineer will support EU MDR 2017/745 remediation programs for Class I, II, and III medical devices. Responsibilities include gap assessments, design control remediation, requirements engineering, traceability management, risk management, and technical documentation updates to ensure compliance with regulatory standards.

What Youll Do

- 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 VV teams
- Support creation and review of Clinical Evaluation, PMS, and PMCF related technical inputs where required

What We re Looking For (Must-Haves):
- Experience in Medical Device Product Lifecycle
- Experience with CAPA, RCA, and Traceability
- Experience in Risk Management and application of ISO 14971
- Experience with DHF, DMR, and remediation activities
- Knowledge of Design Control and Design Assurance
- Experience in Systems Engineering and Requirements Engineering
- Familiarity with Regulatory standards including EU MDR 2017/745, ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR

Valuable to Have (Optional - only if mentioned):
- Knowledge of IEC 62366 Usability Engineering
- Knowledge of IEC 60601 series

Qualifications: Bachelor s or masters degree in biomedical, Mechanical, Electronics, Systems Engineering or related

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Medical Device Systems Engineer - EU MDR Remediation (Pune)
🏢 Proffer IT Consultancy
📍 Pune