Process Engineer

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.

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