Job Title
Device Development Assurance Engineer
Our Pharmaceutical client in Dublin is hiring a Principal Device Development Assurance Scientist/Engineer. This role will make an impact 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).
* 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.
* Establish, maintain and provide guidance on the contents of Design History Files for development programs.
* Collaborate with affiliated sites, collaborators and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
What you'll need to succeed
* Education – Degree / Masters in engineering or science/life science
* Industry – Medical Device or Pharmaceutical (with devices)
* Min 5–7 years at similar level/ or 5–10 years general experience in industry
* Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment
* Experience in the implementation of device design controls and ISO/FDA requirements as applicable to device design
* Demonstrated understanding of GMP, 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)