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.

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