R&D Project Engineer

Location - Sligo GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. The Role We are seeking a creative and hands-on R&D Project Engineer to drive the design and development of new medical devices, with a strong focus on catheter technology. You will be a key player in the entire product lifecycle, from initial concept and prototyping to regulatory submission and manufacturing transfer. This role is perfect for a problem-solver who thrives in a fast-paced R&D environment. Key Responsibilities Design & Development : Lead the design of innovative catheters and other Class I / II / III medical devices using SolidWorks. Prototyping : Rapidly build and test new concepts using hands-on skills, including 3D printing and various lab processes. Regulatory Compliance : Ensure all design work and documentation adhere to the quality management system (ISO 13485) and meet design controls for FDA & CE submissions. Collaboration : Work closely with cross-functional teams, including Quality, Regulatory, and Manufacturing, to ensure project success. Skills & Qualifications Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field. Proven experience in medical device design, with a strong preference for catheter design. Expert proficiency in SolidWorks. In-depth understanding of the design process and controls within an ISO 13485 environment. Excellent hands-on skills in prototyping and lab testing. To start the process click the Continue to Application or Login / Register to apply button below.