Device Development Assurance Engineer
Our Pharmaceutical client in Dublin is seeking a Device Development Assurance Scientist/Engineer to support device development programs throughout the design and development lifecycle for Combination products.
The ideal candidate will ensure 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 by ensuring compliance with design control requirements.
* 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.
* Support the integration and assess compliance with design control requirements of acquired combination products into the Global Device Development product portfolio.
Key Responsibilities:
* Implement Risk Management activities for development programs through the implementation of ISO 14971:2019
* Develop and maintain Design History Files for development programs
* Collaborate with cross-functional teams to ensure effective device development and manufacturing operations
* Ensure compliance with quality management system and regulatory requirements
Required Skills and Qualifications:
* 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