Collins McNicholas

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. 

Major Duties and Primary Responsibilities

  • 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 ongoing basis
  • Work closely with manufacturing engineers during the handover period to commercial operations

Skills & Qualifications

  • Qualified to degree level in engineering, science or related discipline
  • Knowledge of PTCA/stent catheter manufacturing processes essential
  • Strong technical ability (hands on)
  • 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 with design control and ISO13485
  • 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

For confidential disscussion on the role and company call Chris O Toole now on 091 706 713 or send your CV to christopher.otoole@collinsmcnicholas.ie

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