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Principal Design Engineer Job Opening In Meath – Now Hiring hays-gcj-v4-pd-online


Job description

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 plans and timelines.
  • Collaborate with, and influence, affiliated sites, collaborators and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
  • Support the integration, and assess compliance with design control requirements, of acquired combination products and medical devices, into the Global Device Development product portfolio.
  • Support Risk Management activities for development programs through the implementation of ISO 14971:2019

    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

    Required Skill Profession

    Engineers


    • Job Details

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