Company DescriptionSalt Medical is an international medical device Contract Development and Manufacturing Organization (CDMO) with a global R&D and manufacturing network. With R&D centers in Ireland and the U.S. and large-scale manufacturing facilities in the Asia-Pacific region, we specialize in designing and producing innovative products such as catheters, guidewires, medical endoscopes, and surgical robots. Our expertise spans cardio, neuro, endovascular, digestive, and respiratory applications. Utilizing a synergistic global network, we deliver cost-effective and responsive services to medical device manufacturers worldwide.ROLE SUMMARYSalt Medical 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.RESPONSIBILITIESSupport 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.QUALIFICATIONS & EXPERIENCEA minimum of 5–7 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.DESIRABLE ATTRIBUTESExperience working in a regulated medical device environment.Exposure to customer interactions and stakeholder management.Ability to manage multiple tasks and priorities efficiently.A proactive attitude and willingness to take initiative.