Design Assurance Engineer - Hybrid
Co. Wexford
Our client is a well established multinational MedTech corporation in the Wexford region, who are actively expanding within the plant.
Why Apply for this Role?
* Competitive remuneration
* Benefits including pension, health care, life assurance and more!
* Hybrid and flexible working options
* Proven career development trajectories
Key Responsibilities:
* Support cross-functional teams in implementing and maintaining design control procedures throughout the product development lifecycle.
* Ensure compliance with applicable regulatory standards (e.g., FDA QSR, ISO 13485, ISO 14971).
* Review and approve design documentation, including design inputs, outputs, verification, validation, and design changes.
* Lead and support risk management activities (e.g., FMEA, fault tree analysis).
* Participate in design reviews and ensure proper documentation of review activities.
* Provide quality input during design, development, and testing phases.
* Support the creation and maintenance of Design History Files (DHFs).
Key Requirements:
* Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field.
* 5+ years of experience in medical device design assurance, quality engineering, or product development.
#J-18808-Ljbffr