Project Engineer

We are partnering with a leading global contract manufacturer in the medical device industry to recruit a Project Engineer for their facility in Castlerea, Co. Roscommon. This is an exciting opportunity to join an award-winning company that provides innovative technical solutions to Fortune 500 med-tech companies and high-potential start-ups. If you’re passionate about advancing healthcare and improving patients' lives through cutting-edge medical device manufacturing, this could be the role for you. Key Responsibilities:

1. Provide manufacturing support across various production processes.
2. Lead process improvement projects to enhance efficiency and reduce costs using data-driven analysis.
3. Oversee new product introduction (NPI) projects, introducing new processes and supporting product launches.
4. Conduct process and product validations in line with industry standards.
5. Implement product, process, and material changes with proper validation and change control procedures.
6. Collaborate with cross-functional teams to ensure project success, including quality, production, and supply chain.
7. Maintain compliance with quality and environmental management systems (ISO 9001:2008, ISO 13485).
8. Complete additional project work and duties as assigned.

1. Bachelor’s degree in Engineering or a related discipline (Level 8 or equivalent).
2. Minimum of 3 years' experience in medical device manufacturing or a similar regulated environment.
3. Knowledge of validation protocols and experience in their implementation.
4. Proficiency in AutoCAD and SolidWorks is advantageous.
5. Strong understanding of Lean and Six Sigma principles.