System Engineer

Glauben Technologies; Pune District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Glauben Technologies in Pune is seeking a Medical Device Systems Engineer to drive EU MDR remediation for Class I–III devices. You will perform gap assessments, update design controls, manage risk, and maintain traceability across disciplines.

Work closely with Regulatory Affairs, QA, Mechanical, Software and V&V teams to ensure compliance with EU MDR, ISO 13485 and FDA QMSR. This role requires strong collaboration and documentation leadership.

Qualifications

• Bachelor’s or Master’s degree in Biomedical, Mechanical, Electronics, or Systems Engineering.
• 8–15 years of experience in medical device development and remediation.
• Experience with MDR remediation, Design Controls, and risk management.

Responsibilities

• Perform DHF and Technical Documentation gap assessments against EU MDR 2017/745.
• Review and remediate User Needs, Intended Use, System Requirements, Design Inputs/Outputs.
• Create and maintain requirements traceability matrices linked to risks and verification.
• Lead risk management activities including FMEA, FTA, and benefit-risk assessments.
• Support Notified Body interactions and remediation responses.
• Coordinate with Regulatory Affairs, QA, Mechanical, Software, and V&V teams.

Skills

Systems Engineering

Requirements Engineering

Design Controls

Design Assurance

DHF/DMR remediation

Risk Management ISO14971

Traceability Management

EU MDR knowledge

IEC 62366 Usability

Change Control

CAPA

Root Cause Analysis

Product Development Lifecycle

Education

Bachelor’s or Master’s in Biomedical/Mechanical/Electronics/Systems Engineering

Tools

Windchill

Agile PLM

Teamcenter

Microsoft Office

Job description

Job Description Medical Device Systems Engineer

Position Title: Medical Device Systems Engineer - EU MDR Remediation

Experience: 8-15 Years

Location: Pune

Education: Bachelor’s or Master’s degree in Biomedical, Mechanical, Electronics, Systems Engineering or related

discipline.

Mandatory Skills

• Mandatory Skills - Systems Engineering and Requirements Engineering, IEC 62366 Usability
• Engineering, Design Controls and Design Assurance, DHF, DMR and Technical File remediation, Risk
• Management as per ISO 14971, Traceability Management, Medical Device Product Development Lifecycle,
• EU MDR 2017/745, ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR, good communication skill

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)

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

• Strong communication and stakeholder management
• Analytical problem-solving capabilities
• Ability to work with global cross-functional teams
• Experience leading technical reviews and workshops