Senior Design Assurance Engineer

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Job title: Senior Design Assurance EngineerLocation: Balybrit, GalwayBenefits: Career progression, an excellent salary, 22days annual leave, PRSA and stock options. Company:My client is a privately held clinical stage company who are dedicated to developing a minimally invasive transcatheter solution. You will get the opportunity to work with experts in the structural heart field leading a team of Engineers. Responsibilities:Lead key elements of the Design Review process in compliance to internal procedures including EU and FDA requirementsWork with R&D to establish design specifications and product requirements.Lead key elements of the risk management process and preparation of risk managementIn conjunction with the R&D/Operations teams identify product testing required and write design verification and validation plans, protocols and reportsGeneration and/or review of quality and technical documentation / change requests to support design activities.Support various QA/RA activities including quality management, system reviews, internal & vendor auditsSupports regulatory compliance / submission process. Requirements:Possess Degree / Post-Grad in engineering, biomedical or science degree.4+ years' experience in a medical device manufacturing environment with direct experience in a design assurance role.Working knowledge of the Medical Device Directive (93/42/EEC)/Medical Device Regulation 2017/745 and FDA requirements including Quality System RegulationKnowledge and demonstrated practice of risk management methodologies as per EN ISO14971Experience in mentoring/guiding team members. If you are interested in applying and hearing more about this new opportunity forward a copy of your up to date CV or contact the details mentioned. Looking forward to hearing from you To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales