medical device system engineer eu mdr Remediation

Idexcel; Pune District; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Idexcel seeks a Medical Device Systems Engineer to support EU MDR remediation programs for Class I–III devices from Pune. Role involves gap assessments, design control remediation, requirements engineering, and cross-functional collaboration to ensure compliance with EU MDR, ISO 13485, ISO 14971 and related standards.

The ideal candidate has 8–15 years in medical device systems engineering, with strong knowledge of CAPA, traceability, and regulatory knowledge across MDR/US standards.

Qualifications

• 8–15 years of experience in medical device systems engineering and remediation.
• Experience with EU MDR remediation, design control, and regulatory documentation.
• Hands-on in risk management, traceability, and cross-functional collaboration.

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 RTMs 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.
• 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 Clinical Evaluation, PMS and PMCF technical inputs where required.

Skills

Systems Engineering

Requirements Engineering

Design Controls

Design Assurance

DHF & DMR remediation

Risk Management ISO 14971

Traceability Management

Change Control & CAPA

Root Cause Analysis

Med Dev Lifecycle

Regulatory Knowledge

EU MDR 2017/745

ISO 13485

FDA 21 CFR Part 820 / QMSR

IEC 62366 Usability

IEC 60601

Education

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

Job description

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 2017/45
• ISO 13485
• ISO 14971
• FDA 21 CFR Part 820 / QMSR
• IEC 62366 Usability Engineering
• IEC 60601 series (preferred)