R&D Engineer

IrishJobs

Ireland

Ireland

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About

Location: Ireland Reporting to: R&D Manager / Project Lead Position Summary GerTEK is seeking an innovative R&D Engineer to join our consultancy team, supporting a world-class medical technology client in Dublin. This role focuses on the design, prototyping, and testing of next-generation medical devices. You will be responsible for taking concepts from initial sketches through to design freeze, ensuring all iterations meet clinical needs and rigorous regulatory standards. Key Responsibilities Product Design: Lead the design and development of innovative medical device components and assemblies using 3D CAD modeling. Prototyping: Build and evaluate early-stage prototypes using various rapid prototyping techniques (e.g., 3D printing, machining). Design Verification: Develop test protocols, execute benchtop testing, and perform data analysis to ensure designs meet pre-defined performance specifications. Design History File (DHF): Maintain meticulous documentation in compliance with FDA and ISO standards, including Risk Management (FMEA) and Design Inputs/Outputs. Material Science: Research and select appropriate biocompatible materials and coating technologies for specific clinical applications. Cross-Functional Collaboration: Work closely with Clinical Affairs, Marketing, and Manufacturing to ensure the "Voice of the Customer" is integrated into the design. Requirements & Competencies Education: Degree in Biomedical, Mechanical, or Materials Engineering. Experience: 2-5 years in a Research & Development role within the medical device industry. Technical Skills: Advanced proficiency in SolidWorks/CREO and experience with FEA (Finite Element Analysis) or CFD (Computational Fluid Dynamics) is a plus. Regulatory Knowledge: Strong understanding of ISO 13485, ISO 14971, and the MDR (Medical Device Regulation) framework. Mindset: A creative problem-solver who thrives in a "fail-fast, learn-fast" prototyping environment. #Gertek To start the process click the Continue to Application or Login/Register to apply button below.

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Ireland

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