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Job Description
Project Engineer sought for a leading contract manufacturer of single-use medical devices in Castlerea, Roscommon, with a strong focus on process improvement and project management.
Harmac, a privately held company, provides innovative technical solutions and manufacturing services for leading Fortune 500 med-tech companies and high potential start-ups.
The Project Engineer will have an excellent understanding of engineering principles, theories, concepts, practices, and techniques, and will provide manufacturing support, implement process improvement initiatives, and lead projects across a range of product lines.
- 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.
- 3 years' experience in a medical device manufacturing engineering role.
- Knowledge of medical device validation protocols and associated documentation.
- Implementation experience of validation protocols.
- Knowledge of Auto CAD and Solid Works.
- Lean and six sigma knowledge.
- Strong process engineering background.
- Good understanding of ISO 9001: 2008 and ISO 13485.