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Job Title Location Salary  
Senior Product Engineer Dublin Not Disclosed
Balloon Development Engineer Galway Not Disclosed



Other Medical Device Jobs

Job Title Location Salary  
Validation Engineer Limerick Not Disclosed
Manufacturing Engineer Galway €40000 - €45000
Senior R&D Engineer Dublin Not Disclosed
Automation Mechanical Design Engineer Galway Not Disclosed
Senior R&D Engineer Dublin Not Disclosed
Validation Manager Dublin Not Disclosed
Quality and Regulatory Assurance Specialist Cork €45000 - €50000
Programme Manager Cork Not Disclosed
Senior Quality Engineer Galway €45000 - €50000

Process Development Engineer Career Profile

Process Development Engineer

A Process Development Engineer or New Product Introduction Engineers is charged with taking a concept or a prototype from small scale into full scale commercialisation. Process Development Engineers require a strong project management background as the role is cross functional and requires interaction with many different groups, R&D, Quality, Manufacturing, Reg Affairs etc Very often role will require international travel as R&D facility may be located in a different country to manufacturing facility

Typically the Process Development Engineer will have a degree in Engineering and 2-3 years experience in scales up, tech transfers and commercialisation projects. Good communication skills are essential.

Key Responsibilities of the Process Development Engineer


  • Co-ordinating all activities to design, develop and introduce to production new products in accordance with the requirements of ISO 13485:2003 & latest Medical Device Directive & other standards that may apply.
  • Co-ordinating the generation of Design Files, Technical Files and Project Files to include Design Objectives, Design Reviews, Design Outputs, Design Verifications, Shelf Life studies, Bio-compatibility, Sterilisation, Risk Analysis, Validation Master Plans, IQ's, OQ's, PQ's, Test regimes etc., as required for new products and significant changes in existing products.
  • Co-ordinating the activities required to develop new products and processes.
  • Co-ordinating the acquisition of new materials required for new products
  • Co-ordinating the acquisition of new equipment and tooling required for new products, including test and measurement equipment.
  • Supporting the Business Acquisition process in providing technical support, drawings/specifications, samples, costing data and other information that may be required to generate new business.
  • Supporting the production department, especially with regard to new products, with regard to process issues, CAPA's, Engineering Changes, Customer complaints etc as and when required.
  • Ensuring all activities are carried out according to the relevant Medical and Industry standards and internal procedures.
  • Provide accurate and up-to-date reporting on projects





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