Manufacturing Engineer
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 role with responsibility for manufacturing and assembly processes, equipment and process validation, NPI, engineering changes 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 teams.
-
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 identify opportunities to improve process performance.
-
Drive continuous improvement initiatives focused on quality, efficiency and waste reduction.
-
Ensure manufacturing processes comply with relevant SOPs, production systems and quality requirements.
-
Work closely with Engineering, Production, Quality and other functions to deliver project and operational objectives.
-
Maintain awareness of developments in manufacturing technologies and materials relevant to the business.
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 highly regulated industries will also be considered.
-
Significant experience in equipment and process validation is essential.
-
Experience in manufacturing/process engineering, continuous improvement and technical problem solving.
-
Experience supporting NPI, engineering changes or customer projects.
-
CAD experience, ideally SolidWorks, is desirable.
-
Experience with Minitab or statistical analysis is desirable.
-
Strong investigative, analytical and problem-solving skills.
-
Excellent communication and cross-functional working skills.
The Opportunity
This is an opportunity to join an established medical device manufacturing environment in a broad engineering role, with exposure to validation, NPI, process development, customer projects, tooling and continuous improvement.
