Job Description
Were currently recruiting for an exciting opportunity with a Medical Device organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties - Support new product design and development, design transfer, design validation, design review, risk management, etc. working closely with Device Engineering through the entire product life cycle. - Design control compliance ensuring consistent, workable and compliant planning, development (inputs, outputs and review), testing (verification, validation and review), and change management; - Regulatory compliance: ensuring product development (including software) and maintenance in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304 and relevant guidance documents (FDA, etc) - Design risk management, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971) and industry practices, - Supervision of and contribution to pre- and post- market risk assessments; - Interact with other functions such as Global Design Engineering (GDE), Manufacturing, Regulatory, Product Monitoring, Clinical and Operations as necessary - Perform internal and supplier audits - This role may be required to lead personnel (inside and outside) within the Quality organization in support of the business need - Supplier qualification, vendor management and performance evaluation Education & Experience - Bachelor degree in science, microbiology, engineering or equivalent technical field with 8+ years of applicable industry experience is required or a MS with 4+ years of applicable industry experience is required. - Experience in medical device design control including software development and product realization - Competence in statistical tools including design of experiments and sampling methods - Experience in design quality assurance, risk management - Problem solving skills e.g root cause analysis and CAPA implementation - Understanding of one or more subsystem technologies: electrical, mechanical pneumatic and / or software systems - Understanding of human factors and user-interface design - Knowledge of medical device regulations including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971, etc. - Lead auditor certification - Experience in supplier management If interested in this posting please feel free to contact Sen McCarthy on or for further information. Skills: Design quality Medical device Supplier management