Are you looking for the next step in your career with a leading medical device company in Galway? Then we are looking for you!ResponsibilitiesResponsibility for the improvement, optimisation, and implementation of manufacturing process/assembly steps and operating procedures for replicate equipment and processes within a regulated quality system.Lead and support equipment/process qualifications including protocol development and execution.Develop and maintain project timelines and provide updates and feedback to project leadership.Implement problem solving skills and techniques to identify potential process risks, assess their impact, developing and implementing mitigation plans.Plan and perform Design of Experiments (DOE) and utilise six sigma methodologies to characterise, assess capabilities, and determine optimal processing operating windows.Consult with vendors to produce equipment, materials, and/or parts that meet determined product specifications.Perform statistically robust and industry standard analysis of data, and present findings to technical teams. You will exercise judgement within defined procedures and policies to determine appropriate action.What we need from you?Bachelor’s degree in a technical discipline, and a minimum of 13+ years related experience or a Master’s degree and 8+ years equivalent industry experience or a PhD and 5+ years of experience.Ability to run self-directed projects, maintain timelines, stay organised, and balance multiple activities in a fast-paced environment.Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.Knowledge of high reliability, high volume manufacturing processes and designs.
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