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Design & Development Engineer – medical devices

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A highly innovative medical device manufacturer in the Newport area currently require an experienced Design & Development Engineer to join their team. The successful Design & Development Engineer will be working on the next generation of new products, from initial concepts through regulatory compliance, production and to market. You will be working on genuinely innovative and high tech products which will have a huge impact on peoples lives.On offer is a highly competitive salary and benefits as well as the opportunity to work on genuinely innovative products within a rapidly growing company who can offer career progression, training and development opportunities for the right candidate.Responsibilities:Design and Development activities in accordance with quality management systemAssist with all project related tasks required to progress development of productsRegulatory submission and approvalPreparation of technical documents such as risk analysis, FMEA, component specifications, technical reports including verification and validation reports etc. for incorporation into the technical file.Development and execution of V&V test fixtures and tests.Support required documentation & processes for CE MarkingExecution of design improvements and cost-out activitiesAssembly of small volumes of prototype accessories for design proving and V&V activitiesDrafting and refinement of manufacturing instructions, jigs, tools and procedures for the productDrive continuous improvement as part of the Quality Management System.Experience/Skills:Degree educated in a relevant engineering disciplineExperienced Mechanical Design/Development EngineerCAD proficiency (ideally SolidWorks)Experience working within the medical device industry with knowledge of ISO 13485Engineering and root cause analysis problems solving skillsGood interpersonal and communication skillsAn excellent can-do attitudeAbility to uphold the highest quality standards

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