Process Engineer – Medical Device - South Wales – 6 Month Contract
About the Company:
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.
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.
* Undertake additional reasonable duties as necessary to support operational requirements and fulfil customer demand.
Requirements:
* Medical device process engineering experience.
* Available to start within 1 week.
* A knowledge of medical device FDA requirements.
* Excellent communication skills.
* Technical transfer or NPI experience.