Manufacturing Engineer

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.