System Engineer

Tailoredcare; Pune District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Tailoredcare is seeking a Systems Engineer to support EU MDR remediation programs for Class I, II and III medical devices. The role covers gap assessment, design control remediation, requirements engineering, traceability management, risk management, technical documentation updates and cross-functional collaboration to achieve compliance with EU MDR and ISO standards.

The ideal candidate will have system engineering experience in the medical device domain and hands-on involvement with DHF

Qualifications

• System engineering in the medical device domain
• DHF remediation and gap assessment
• V-model development lifecycle
• Requirements drafting and trace matrix management
• DFMEA and risk management
• Knowledge of EU MDR 2017/745, ISO 13485 and ISO 14971

Responsibilities

• Support EU MDR remediation programs for Class I, II and III medical devices.
• Perform gap assessment and lead design control remediation activities.
• Contribute to requirements engineering and create trace matrices.
• Update technical documentation and support cross-functional collaboration.

Skills

System engineering in medical device

DHF remediation and gap assessment

V-model development lifecycle

Requirements drafting and trace matrix

DFMEA and risk management

EU MDR 2017/745, ISO 13485 and ISO 149

Job description

Role overview

The Systems Engineer will support EU MDR 2017/745 remediation programs for Class I, II and III medical devices. The role covers gap assessment, design control remediation, requirements engineering, traceability management, risk management, technical documentation updates and cross-functional collaboration. The goal is compliance with EU MDR, ISO 13485, ISO 14971 and applicable product standards.

Required skills

• System engineering in the medical device domain (mandatory)
• DHF (Design History File) remediation and gap assessment
• V-model development lifecycle
• Requirements drafting and requirements trace matrix management
• DFMEA and risk management
• Working knowledge of EU MDR 2017/745, ISO 13485 and ISO 14971