Senior Product Development Engineer- Medical DevicePermanentGalwayLocation: GalwayDuration: PermanentRole DescriptionThis job description sets out to define the role of a Senior Product Development Engineer. The role involves leading product development activities across multiple customer projects, ensuring requirements are translated into robust, manufacturable medical device solutions.Duties & ResponsibilitiesLead product development activities across multiple projects, ensuring customer requirements are translated into product specifications for transfer to production.Develop user-focused product solutions optimised for manufacture.Lead concept development, engineering, and design verification stages of new product development.Deliver mechanical design solutions for early-stage and late-stage product development.Perform risk assessment and risk management activities in accordance with ISO 14971.Prototype and test concept designs and early engineering builds.Develop CAD models and tolerance stack-ups using SolidWorks, including complex assemblies and surface modelling.Support pilot production trials to assess feasibility and mitigate design risks.Develop product specifications, test methods, and associated documentation.Perform statistical analysis of test data using Minitab or equivalent tools.Lead design verification activities including protocol development and execution in line with ISO 13485 requirements.Collaborate with design teams on product validation and usability testing.Lead and participate in customer design and technical reviews.Work closely with process development and production teams to support transfer to manufacturing.Support project planning, scheduling, cost tracking, and reporting activities.Develop project proposals outlining cost, schedule, and risk and present these to customers.Support quality investigations, root cause analysis, and design improvement initiatives.Education & Experience RequiredMinimum of 6 years' experience in medical device product development, ideally within highly regulated Class III environments.Strong understanding of manufacturing methods, mechanisms, materials, tolerance analysis, and design for manufacturing.Extensive experience translating design inputs into engineering outputs, tolerance stack-ups, and product testing.Strong knowledge of medical device design controls, design verification and validation, and FMEAs.Experience working within GMP, QSR, ISO 13485 and other relevant quality systems.Demonstrated experience in medical device risk management and associated documentation.Excellent problem-solving, decision-making, and root cause analysis skills.Experience designing for manufacturability, particularly for plastic components, and managing suppliers.Strong project management experience from concept through delivery.Excellent written and verbal communication skills.Proven experience working within and leading cross-functional product development teams.Proficiency in SolidWorks and Microsoft Office.
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