Manufacturing Engineer
Location: Waterford
A leading medical device manufacturing organisation is seeking an experienced Manufacturing Engineer to join its engineering team in Waterford.
This is a hands-on engineering role focused on manufacturing and assembly processes, equipment and process validation, NPI and continuous improvement within a regulated manufacturing environment.
Key Responsibilities
- Manage and execute equipment and process validation activities.
- Support customer engineering changes and ensure ECNs are implemented effectively and within agreed timelines.
- Take the lead on assigned New Product Introduction (NPI) projects, working closely with customers and internal departments.
- Define and own manufacturing and assembly processes, including process routings and associated subcontract processes.
- Manage the First Article Inspection (FAIR) process and complete First Article reports.
- Provide technical support for new and existing manufacturing projects.
- Prepare in-house engineering drawings and provide CAD support.
- Develop and support the introduction of jigs, fixtures and tooling.
- Investigate manufacturing issues and implement appropriate corrective and improvement actions.
- Drive continuous improvement initiatives focused on quality, efficiency, process performance and waste reduction.
- Ensure adherence to manufacturing processes, SOPs and production systems.
- Work collaboratively with Engineering, Production, Quality and other functions to achieve project and operational objectives.
Requirements
- Bachelor’s degree in Engineering or a related discipline.
- Ideally 5+ years’ relevant Manufacturing or Process Engineering experience.
- Experience within medical devices is preferred; candidates from pharmaceuticals or other regulated industries will also be considered.
- Significant experience in equipment and process validation is essential.
- Strong understanding of manufacturing and assembly processes.
- Experience with NPI, engineering changes or customer projects.
- CAD experience, ideally SolidWorks, would be advantageous.
- Experience with Minitab or statistical analysis would be advantageous.
- Strong analytical, investigative and problem-solving skills.
- Ability to work effectively across multiple functions in a manufacturing environment.
The Opportunity
This is an opportunity to join an established medical device manufacturing operation in a broad engineering role, with exposure to validation, NPI, process development, customer projects, tooling and continuous improvement.
If you are an experienced Manufacturing or Process Engineer looking for your next opportunity in the Waterford area, please get in touch.
