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IntaPeople Limited
,
Bristol, Bristol
Process Engineer
Overview
A highly innovative medical device manufacturer in the Bristol area currently require a contract Process/Manufacturing Engineer to join their team on an initial 6-month contract. This company are genuinely revolutionising certain surgical procedures and the successful candidate/contractor will be working on high tech, innovative products which will have a huge impact on people's lives. The role will be assisting with qualification, verification and validation of processes through the build and test process of a high tech and innovative medical device. They are open to both an hourly/daily rate contract or a 6-month fixed term position. On offer is a highly competitive rate. The successful candidate/contractor should be an experienced Process/Manufacturing Engineer within the medical device industry and be a validation expert. Responsibilities: Product and process Validation and Verification - including IQ/OQ/PQ, DOE and TMQs PFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processes Design of jigs and fixtures using SolidWorks 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 Support internal audits and work under ISO 13485 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) & GDP (Good Documentation Practice) throughout manufacturing Coordinate the training of Manufacturing Operators and act as a mentor and technical resource Development of manufacturing and verification of jigs and fixtures Experience/Skills: Expert in product and process Validation and Verification - including IQ/OQ/PQ, DOE and TMQs. Familiar with PFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processes Expertise with statistical process control (SPC, CPK's etc.) Excellent engineering and root cause analysis problems solving skills Cleanroom experience (ISO class 7/8) Familiarity with ISO 13485 SolidWorks experience IntaPeople is acting as an Employment Business in relation to this vacancy. By applying for this job you accept the privacy policy which can be found on our website. Your details will never be submitted to a client without your explicit consent. This job was originally posted as www.totaljobs.com/job/89884224