Job Description
We’re 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.DutiesSupport 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 & ExperienceBachelor 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 Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information. #J-18808-Ljbffr