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Process Development Engineer Career Profile
Process Development EngineerA 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