Process Development Engineer Career Profile

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