Job Summary

Support EU MDR remediation programs through requirements engineering, design control remediation, traceability, risk management, technical documentation, and cross-functional collaboration

Responsibilities

- Support EU MDR remediation activities for Class I, II, and III medical devices
- Perform gap assessments and support design control remediation
- Develop and maintain system and product requirements
- Prepare and maintain Requirements Traceability Matrices (RTM)
- Support risk management and DFMEA activities
- Review and update technical and design documentation
- Ensure traceability between requirements, risks, design outputs, and verification activities
- Participate in design reviews and cross-functional discussions
- Support compliance activities throughout the product development lifecycle
- Work closely with engineering, quality, regulatory,



and other cross-functional teams

Qualifications

- Hands-on experience in system engineering within the medical device domain
- Experience in DHF remediation and gap assessment
- Understanding of the V-Model development lifecycle
- Experience in requirements drafting and requirements traceability
- Knowledge of DFMEA and risk management
- Working knowledge of EU MDR 2017/745, ISO 13485, and ISO 14971
- Robust documentation and communication skills

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 System Engineer - Medical Devices / EU MDR (Pune)
🏢 Code Work It Solutions
📍 Pune