Our client in Castlerea, Roscommon is looking to add a Project Engineer to their growing team.
Our client is a leading, award-winning contract manufacturer of single-use medical devices, serving the global marketplace for more than 35 years. With headquarters in Buffalo, NY, and facilities in Ireland and Mexico, this opportunity is based in their Irish site in Castlerea, Co. Roscommon. Harmac, a privately held company, provides innovative technical solutions and manufacturing services for leading Fortune 500 med-tech companies and high potential start-ups.
Main Purpose and Objective of the Position:
Reporting to a Business Unit Engineering Manager, the Project Engineer will have an excellent understanding of engineering principles, theories, concepts, practices, and techniques. The Project Engineer will provide manufacturing support, implement process improvement initiatives, and lead projects across a range of product lines.
Responsibilities:
* Provide manufacturing support over a range of manufacturing processes.
* Lead process improvement initiatives to reduce cost and improve manufacturing efficiency by using data analysis.
* Manage projects and lead new product introduction projects, introducing new processes as appropriate.
* Carry out process and product validations.
* Implement product, process, and material changes through validation, change control, and documentation updates.
* Familiarize yourself with a variety of processes to allow you to work across a number of product lines.
* Conform to the requirements of the quality and environmental management system.
* Additional ad hoc duties and projects as assigned.
Qualifications and Skills:
* Level 8 or equivalent Degree in Engineering or similar discipline is desirable.
* 3 years’ experience in a medical device manufacturing engineering role is desirable.
* Knowledge of medical device validation protocols and associated documentation.
* Implementation experience of validation protocols.
* Knowledge of AutoCAD and Solid Works is desirable.
* Lean and six sigma knowledge.
* Strong process engineering background.
* Good understanding of ISO 9001: 2008 and ISO 13485.
For further details please contact: Colin Clare on +353 87 060 8656 or send CV to colin.clare@lifescience.ie
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