Principal Design Engineer

Your new company

Here in Hays Recruitment, our Pharmaceutical client in Dublin is hiring a Principal Device Development Engineer.
Your new role
Here’s how the Principal Device Development Assurance Scientist/Engineer role will make an impact:

Support and provide guidance for device development programs throughout the design and development lifecycle for Combination products, including prefilled pens, prefilled syringes, auto-injectors, and medical devices, by ensuring compliance with design control requirements outlined in Quality Management System, and relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971).

Establish, maintain and provide guidance on the contents of Design History Files for development programs, for various program types – in-house design authority, collaborative development, and acquired programs; this shall include associated activity plan...