Senior Project Engineer

2 weeks ago

Galway, Ireland Life Science Recruitment Full time

Job title:Senior Project Engineer Location: Claregalway, Galway Company: My client are a leading CDMO specialising in the design, development, and manufacturing of advanced medical devices. With in-house polymer and metal component production, rapid prototyping, and ISO Class 8 cleanroom facilities, they support end-to-end development of products such as catheters, guidewires, endoscopes, and surgical robotics technologies. Their solutions NOTAG multiple clinical areas, including cardiovascular, neurovascular, endovascular, digestive, and respiratory applications. Job Overview: My client is seeking a Senior Project Engineer to support the Technical Manager in the execution of R&D and product development projects. This role will involve hands-on engineering work, coordination with cross-functional teams, and contribution to the development of innovative MedTech solutions. The Senior Project Engineer will work within the company’s Quality Management System (QMS) and support the delivery of high-quality, compliant, and timely project outcomes. Experience Required: A minimum of 4–6 years’ experience in R&D or product development, preferably in the MedTech or Biotech industry.Proven experience in supporting the development of new products from concept through to production.Familiarity with design control processes and regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820).Strong problem-solving skills and hands-on engineering capabilities.Proficiency in engineering tools and software (e.g., CAD, FMEA, risk analysis tools).Excellent communication and documentation skills.Ability to work effectively in a team-oriented, fast-paced environment.Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field. 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. Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on 087 0608656 ORcolin.clare@lifescience.ie

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