Overview
Salt 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 design and produce innovative products such as catheters, guidewires, medical endoscopes, and surgical robots for cardio, neuro, endovascular, digestive, and respiratory applications.
Salt Medical is seeking a Senior Project Engineer to support the Technical Manager in the execution of R&D and product development projects.
This role involves hands-on engineering work, coordination with cross-functional teams, and contributing to the development of innovative MedTech solutions.
The Senior Project Engineer will operate within the company's Quality Management System (QMS) and support the delivery of high-quality, compliant, and timely project outcomes.
Responsibilities
Support the Technical Manager in planning and executing R&D projects, including product development, testing, and documentation.
Coordinate 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 *****, 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 & Experience
A 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 *****, 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 Attributes
Experience 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.
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