Medical Device Systems Engineer - EU MDR Remediation

Proffer It Consultancy; Pune District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

BinQle is seeking a Medical Device Systems Engineer to support EU MDR remediation programs for Class I-III devices in Pune. You will lead gap assessments, design controls remediation, and requirements engineering to ensure regulatory compliance.

The role involves traceability management, risk analysis (FMEA/FTA), and collaboration with Regulatory Affairs, QA, Mechanical, Software, and VV teams. 8–15 years of domain experience is expected.

Qualifications

• Experience with medical device product lifecycle and regulatory compliance.
• Experience with CAPA, RCA, and traceability.
• Knowledge of risk management and ISO 14971.
• Experience with DHF, DMR, and remediation activities.
• Familiarity with Design Control and Design Assurance.
• Experience in Systems Engineering and Requirements Engineering.
• Familiar with EU MDR 2017/745, ISO 13485, FDA 21 CFR Part 820/QMSR.

Responsibilities

• Perform 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 per MDR Annex II/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/review of Clinical Evaluation, PMS, and PMCF inputs.

Skills

Medical device lifecycle

CAPA & RCA

Risk management

DHF/DMR remediation

Design Control

Systems Engineering

Requirements Engineering

EU MDR knowledge

Education

Bachelor/Master in Biomedical/Mechanical/Electronics/Systems Engineering

Job description

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

Good 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