We are partnering with a client in the medical device industry who is seeking a dedicated Senior R&D Engineer to join their innovative team in Galway. This early-stage start-up is focused on developing life-changing solutions for palliative care patients. If you are passionate about making a positive impact and thrive in a fast-paced, multidisciplinary environment, this role offers a unique opportunity to contribute significantly to product development.
Responsibilities: Lead the design and development of medical devices, including concept development, human factors engineering (HFE), prototype development, and design for manufacturing (DFM).Develop and validate test methods, ensuring compliance with regulatory requirements.Collaborate with vendors and suppliers to optimise the delivery of services and materials.Prepare technical documentation in line with FDA and EU MDR submissions, including part specifications, technical drawings, and validation reports.Implement problem-solving initiatives, performing advanced data analysis and generating comprehensive reports with actionable recommendations.Ensure adherence to design controls and risk management throughout the product lifecycle.Support pre-clinical testing and usability studies to validate device performance.Facilitate communication and collaboration across the R&D team to drive project success.Requirements: Bachelor's degree in Science, Engineering, or a related field.Minimum of 5 years' experience in medical device R&D, with a focus on design controls, verification/validation, and process FMEAs.Proven experience in device design and development, including material selection and test method development.Proficiency in CAD software (SolidWorks) is essential.Why Join Us? Be part of a dynamic start-up environment with a focus on innovative medical solutions.Flexible working hours (Core hours 10-4 Mon to Thurs and 10-1 on Friday).The opportunity to work in a state-of-the-art innovation hub.Contribute to a meaningful project that improves the quality of life for patients.
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