System Engineer

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 - 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