• Process Development Engineer

    Job Locations IE-Galway
    Job Post Information* : Posted Date 4 months ago(10/11/2018 1:04 PM)
    # of Openings
  • Overview

    Reporting to the R&D Manager, the Process Development Engineer will be involved in the project of transitioning a PTCA stent catheter from R&D to commercial phases. The engineer will work on both R&D and process development elements in this and other projects. The engineer will be technically competent as well as competent in problem solving, data analysis, report writing and project management skills.


    • Qualified to degree level in engineering, science or related discipline
    • Knowledge of PTCA/stent catheter manufacturing processes essential
    • Strong hands-on technical ability
    • Technical drawing experience essential
    • Knowledge in the use/processing of a variety of materials (plastics, metal, adhesives, etc.)
    • Understanding/working knowledge of relevant FDA/BSI standards and regulatory requirements
    • Experience in risk management/IS014971
    • Strong project management and leadership skills essential
    • Strong report writing skills essential
    • Good working knowledge of statistical and structured problem-solving techniques 


    • Manage projects transitioning from R&D to commercial phases
    • Complete evaluation, testing, analysis and reporting to establish performance of various products/processes
    • Schedule and manage development builds and testing
    • Specify, source, test and approve material  
    • Prepare and lead reviews, including R&D design reviews
    • Create and maintain design-related technical information (lab notebooks, protocols, validations, manufacturing documents, etc.) to support design history file
    • Train operators/trainers in various new process steps
    • Understand and troubleshoot complex processing equipment
    • Support other R&D projects on an on-going basis
    • Work closely with manufacturing engineers during the handover period to commercial operations


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