Job Summary
We are seeking a Principal Device Development Engineer to support our Pharmaceutical client in Dublin. This role will make an impact by ensuring compliance with design control requirements and collaborating with affiliated sites to establish objective evidence and controls.
Key Responsibilities:
* Support device development programs: Provide guidance throughout the design and development lifecycle for Combination products, including prefilled pens, prefilled syringes, auto-injectors, and medical devices.
* Maintain Design History Files: Establish, maintain and provide guidance on the contents of Design History Files for development programs, including associated activity plans and timelines.
* Collaborate with stakeholders: Work with affiliated sites, collaborators and third parties to ensure appropriate objective evidence and controls are established and maintained.
* Support integration and compliance: Integrate acquired combination products and medical devices into the Global Device Development product portfolio and assess compliance with design control requirements.
* Risk Management: Support Risk Management activities for development programs through the implementation of ISO 14971.
Requirements:
* Education: Degree/Masters in engineering or science/life science.
* Industry experience: Medical Device or Pharmaceutical (with devices) with min 5-7 years at similar level/ or 5-10 years general experience in industry.
* Direct experience: Device development and manufacturing operations activities for device or drug/device systems in a GMP environment.
* Knowledge: Implementation of device design controls and ISO/FDA requirements as applicable to device design, 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).
We offer:
* Competitive salary:
* Bonus scheme: