Job Description
Job title: Senior Design Assurance EngineerCompany: Mason AlexanderJob description: I am working with a leading Medical Device company in Galway, to recruit for a Senior Design Assurance Engineer to join their team on a permanent basis. The Senior Design Assurance Engineer in this role will be responsible for full product lifecycle, including oversight of all sustaining activities, and will play a key role in New Product Development and EU MDR projects. This role will be a key contributor to the development of the Risk Management and Design Control Systems, as well as providing Design Assurance input for commercial activities, including leading in Verification and Validation for Design Change, managing Design History files, and leading on Risk Management for assigned projects.Responsibilities:Support the development of the Design Control, Risk Management, and associated systems (e.g., labelling/packaging).Lead sustaining activities with a specific focus on design changes to meet business needs in line with updated standards and regulatory requirements and assess product impact with integration into QMS as required.Lead the risk management activities for assigned projects in line with ISO 14971 and company procedures.Develop and maintain design verification and validation plans, protocols, and reports for design changes.Design, development and validation of test methods as required to support development programs.Lead Human Factors / Usability Engineering activities and maintain Usability Engineering File for assigned projects.Manage the system for Design History File creation and maintenance for new and commercialised devices ensuring regulatory and procedural requirements are met.Lead all risk management activities related to design changes.Requirements:5+ years of experience in a Quality or Design Assurance role in the Medical Design industry, ideally working with Class III Medical Devices.Bachelor’s degree or higher in Science, Engineering, or a related discipline.An excellent understanding of ISO 13485 and ISO 14971 Quality and Risk Management systems is essential, as is a good understanding of statistics and validation.Expected salary:Location: GalwayJob posting date: Fri, 19 Jul 2024 02:39:19 GMTApply for the job now! #J-18808-Ljbffr