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James Cassidy
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Search Results for Process Development Engineer
Job Title. Location Salary Actions

Principle Engineer

Great opportunity for an experienced engineer to to join a well-known medical device company in Cork. In this role you will act as the Principle Engineer workin

Location: Cork, Cork City,
Principle Engineer
Cork Not Disclosed

Process Development Engineer

Process Development Engineer In support of its ongoing medical device development programme, our client currently requires a Process Development Engineer, to support product and process development activities Role/Responsibilities • Development of Class III medical devices and associated manufacturing processes, entailing: o Device development based on outputs from product/process improvement feedback o Process development to facilitate manufacture of product, including implementing appropriate process controls o Development and validation of test and inspecti...

Location: Dublin,
Process Development Engineer
Dublin Not Disclosed
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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