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| Job Location | Bristol |
| Education | Not Mentioned |
| Salary | 35,000 - 45,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
A highly innovative medical device manufacturer currently require a ProcessEngineer to join their team.This company are genuinely revolutionising their fieldand the successful candidate will be working on high tech, innovative products which will havea huge impact on peoples 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 products.On offer is a highly competitive salary and benefits package. The successful candidate 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 TMQsPFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processesDesign of jigs and fixtures using SolidWorksManufacturing of devices containing small parts and low volume manufacturingIdentify process problems and non-conformances in manufacturing processes and develop corrective actionsDefine and perform maintenance and calibration proceduresDrive continuous and process improvementsSupport internal audits and work under ISO 13485Review 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 drawingsParticipate 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 launchesImplement GMP (Good Manufacturing Practices) & GDP (Good Documentation Practice) throughout manufacturingCoordinate the training of Manufacturing Operators and act as a mentor and technical resourceDevelopment of manufacturing and verification of jigs and fixturesExperience/Skills:Expert in product and process Validation and Verification - including IQ/OQ/PQ, DOE and TMQs.Medical device industry experience is essential for the roleExpertise with statistical process control (SPC, CPKs etc.)Excellent engineering and root cause analysis problems solving skillsFamiliar with PFMEA, MVP, Process flow, manufacturing plan, manufacturing instructions, manufacturing travellers & packaging processesCleanroom experience (ISO class 7/8)Familiarity with ISO 13485SolidWorks experience