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.

• 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.