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:
As a Project Engineer, you will:
* Provide manufacturing support across various production processes.
* Lead process improvement projects to enhance efficiency and reduce costs using data-driven analysis.
* Oversee new product introduction (NPI) projects, introducing new processes and supporting product launches.
* Conduct process and product validations in line with industry standards.
* Implement product, process, and material changes with proper validation and change control procedures.
* Collaborate with cross-functional teams to ensure project success, including quality, production, and supply chain.
* Maintain compliance with quality and environmental management systems (ISO 9001:2008, ISO 13485).
* Complete additional project work and duties as assigned.
Requirements:
* Bachelor’s degree in Engineering or a related discipline (Level 8 or equivalent).
* Minimum of 3 years' experience in medical device manufacturing or a similar regulated environment.
* Knowledge of validation protocols and experience in their implementation.
* Proficiency in AutoCAD and SolidWorks is advantageous.
* Strong understanding of Lean and Six Sigma principles.
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