Process Development Engineer

Responsibilities: 1. Provide design and development support to products post launch, coordinating design and manufacturing changes and improvements to meet defined device and manufacturing requirements. 2. Accept the introduction of new products and ensure their efficient on-going transition into regular production by appropriate provision of a design authority service to operations and quality. 3. Assessment of Non Conformance Reports (NCRs) and implementation of agreed corrective / preventative actions to maintain regulatory compliance. 4. Maintain a strong and current understanding of relevant new product development and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs. 5. Evaluate and document the feasibility, reliability and risk to of changes to product designs and manufacturing processes through engineering design, analysis & testing to demonstrate the product performance, manufacturability, material selection, safety and cost are consistent with the customer and regulatory requirements. 6. Develop timelines and cost estimate for development tasks and appraise management of performance against plan to maintain compliance to project schedule. 7. Generate and review design history file documentation in compliance with Good Manufacturing Practice (GMP), Quality System Regulations (QSR), International Standards Organisation (ISO) and company Product Development Process (PDP) requirements throughout the project life cycle to ensure the design is fully documented. 8. To be responsible for customer contact with respect to company products to ensure maintenance of product line and communication and buy in of design change implementation where required. Qualification: Bachelor's degree in an appropriate Engineering discipline or equivalent with a minimum of 2 years experience in a regulated and highly mechanical engineering design environment OR HNC/D in an appropriate Engineering discipline with a minimum of 5 years experience in a regulated and highly mechanical design environment. This job was originally posted as www.totaljobs.com/job/89954698