Process Engineer – Medical Device – South Wales – 6 Month Contract We are looking for an experienced medical device Process Engineer who is available at short notice to work in a site based role assisting with a technical transfer project, preparing for audit readiness and other process engineering responsibilities.
Provide day-to-day on-site manufacturing and production engineering support. Drive continuous improvement initiatives through optimisation of existing processes and the introduction of new manufacturing processes. Collect, analyse, and interpret manufacturing data, including production control charts, reliability metrics, and process capability studies, to monitor performance and identify improvement opportunities. Ensure the timely maintenance, calibration, and validation of critical production equipment in line with scheduled requirements. Support the design, development, and implementation of production tooling, test equipment, gauges, and manufacturing aids. Collaborate with equipment, component, and tooling suppliers to enhance manufacturing efficiency, capability, and product quality. Generate and execute validation protocols, reports, and supporting documentation to meet regulatory and quality requirements. Support product design transfer activities and engineering change processes from development through to production. Create, review, and maintain quality management system documentation, production procedures, and work instructions. Produce and update technical drawings and engineering documentation as required. Contribute to continuous improvement activities across Quality and Production functions. Support company-wide quality compliance initiatives and adherence to relevant standards and regulations. Assist in the investigation of quality issues, conducting root cause analysis and supporting CAPA implementation and effectiveness verification. Manage and implement engineering and process changes in a timely and controlled manner. Deliver equipment, process, and technical training to production personnel where required. Medical device process engineering experience. A knowledge of medical device FDA requirements….