Manufacturing Engineer - Medical Devices NPI & Validation

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

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.