Medical Devices Process Development Engineer

Medical Devices Process Development Engineer Cardiff / Bristol area £Neg Our client is an innovative medical device company specialising in the design and development of cutting edge electro-mechanical medical devices and due to exciting growth they now have an immediate requirement for a Process Evaluation / Manufacturing Development Engineer responsible for the qualifying of processes and equipment for the introduction of new product to main stream manufacture. Experience in medical product process development, process qualification, jig & fixture design and engineering build management would be valuable. This would suit someone who has worked in medical devices as a product evaluation engineer, new product development engineer, quality engineer or a well-rounded project engineer. Responsibilities include: Design of jigs and fixtures using solid works. Manufacturing of devices containing small parts and low volume manufacturing. Identify process problems and non-conformance’s in manufacturing processes and develop corrective actions. Define and perform maintenance and calibration procedures. Drive continuous and process improvements. Project management. Support internal audits and work under ISO13485. Documentation preparation and control. Review procedures for accuracy and make updates using a Document Change Order to reflect process changes, and develop production procedures, standard operating procedures testing and inspection and drawings. Participate in New Product Development teams to establish quality standards for new products and create process procedures, specifications and work instructions as needed and support new product launches. Implement GMP (Good Manufacturing Practices) throughout manufacturing. Coordinate the training of Manufacturing Operators and act as a mentor and technical resource. Requirements: Experience in using adhesives Laser/ resistance welding skills Advanced Soldering skills PLC control experience Crimping skills Cleanroom experience (ISO class 7/8) Familiarity with ISO13485 Solid works experience Familiarity with statistical process control (SPC, CPK’s etc.) Experience is designing pneumatical powered tooling Experience of working with external tooling companies Familiar with repeatability & reproducibility This job was originally posted as www.totaljobs.com/job/89929108