Job DescriptionA Design Engineer is required to join our Cork based client – an award winning Irish medical device company, developing novel medical devices for the global market. Excellent opportunity to join a professional core team with exposure across engineering & commercial functions.Role of this positionResearch and translate voice of customer and voice of patient information into a series of user needs.Develop concepts (CAD) and prototypes (3D print) of novel medical devices.Contribute to design reviews, offering valuable insights and suggestions to optimise product performance and manufacturability.Provide support for manufacturing of new products with tooling, product design and process validation.Analyse data sets using appropriate statistical techniques and generating reports to summarise the information.Responsible for on-site laboratory testingManage off-site testing labs and test houses required for external testingExecute design controls activities (design verification, design validation and design transfer) per FDA 21 CFR Part 820.Generate design verification/validation protocols and reports.Conduct risk management activities per ISO 14971.Responsible for creation of quality system and regulatory documentation, such as user requirements specifications, design inputs and outputs.Job RequirementsBachelor of Science in Engineering, Mechanical Engineering/Biomedical and 5+ years' experience working for a medical device company whose products and processes are FDA/EU regulated.Experience in design and development of medical devices per ISO 13485 & FDA 21 CFR Part 820, especially design verification and validation.Knowledge of medical device regulations (MDR and FDA) and experience with ISO 14971 and IEC 62366 is an advantage.Experience in generating technical files and regulatory documentation associated with medical devices, such as risk analysis, dFMEA, DIOVV and related documents.Please call Diarmuid Buckley today for further information on or email: CareerWise Recruitment (In Search of Excellence)Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.