Senior Project Engineer (Medical Devices) - Galway

Our client, a new Galway based ‘start up’ international medical device Contract Development and Manufacturing Organisation (CDMO) with a global R&D and manufacturing network is seeking an ambitious and energetic individual for the following position to support the Technical Manager in the execution of R&D and product development projects: Senior Project Engineer (Medical Devices) - Galway1. ROLE SUMMARYReporting to the Technical Manager, this role will involve ‘hands-on’ engineering work, coordination with cross-functional teams, contribution to the development of innovative MedTech solutions work within the company’s Quality Management System (QMS) to support the delivery of high-quality, compliant, and timely project outcomes. 2. RESPONSIBILITIES·        Support the Technical Manager in planning and executing R&D projects, including product development, testing and documentation.·        Assist in the coordination of engineering activities across design, quality, and manufacturing teams.·        Contribute to the development of core technologies and support their transfer into manufacturing.·        Participate in design and development activities, including design input/output, risk management, and verification/validation.·        Prepare and maintain technical documentation in compliance with internal procedures and regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820).·        Provide technical input on material selection, design improvements, and testing strategies.·        Collaborate with Quality, Regulatory, and Manufacturing teams to ensure smooth project execution and product transfer.·        Identify opportunities for process and product improvements and contribute to continuous improvement initiatives.·        Support the mentoring and guidance of junior engineers and technicians as needed.Applicants must have a minimum of 5 years’ experience in R&D or product development, preferably in the MedTech or Biotech industry and possess a Bachelor’s or Master’s degree in Mechanical or Biomedical Engineering, or a related field.Benefits include a highly competitive remuneration package, Healthcare Insurance, Bonus and Pension scheme.Applications please, in strict confidence, by the 5th December 2025 to:John Madden FCIPD   Tel. No.: +353872561442 E-mail: jma@iol.ie john@jmarecruitment.ie