Manufacturing Engineer

Morgan McKinley; Waterford; On-site; EUR 60,000 - 80,000; Full time

Job summary

Morgan McKinley in Waterford is seeking an experienced Manufacturing Engineer to join its medical device manufacturing team. This hands-on role focuses on manufacturing and assembly processes, equipment and process validation, NPI and continuous improvement within a regulated environment.

You will define and own processes, lead NPI projects, manage FAIR, support ECNs, provide CAD support, and drive CAPA across functions.

Qualifications

• Bachelor's degree in Engineering or a related discipline.
• 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.

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.

Skills

Equipment validation

NPI

First Article Inspection

SolidWorks

Minitab

Continuous improvement

Cross-functional collaboration

Process engineering

Problem solving

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Minitab

Job description

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.