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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