Manufacturing Engineer - Medical Devices (NPI & Validation)

Morgan McKinley; Waterford; On-site; EUR 60,000 - 75,000; Full time

Job summary

Morgan McKinley is seeking a Manufacturing Engineer in Waterford to join the engineering team. This role focuses on hands-on manufacturing and assembly processes, equipment validation, NPI, engineering changes and continuous improvement within a regulated environment.

The successful candidate will lead validation activities, support ECNs and NPI projects, and work closely with Engineering, Production and Quality to deliver projects and improve efficiency.

Qualifications

• Bachelor's degree in Engineering or related discipline.
• 5+ years' experience in Manufacturing or Process Engineering.
• Experience in medical devices or highly regulated industries.
• Significant experience in equipment and process validation.
• Experience supporting NPI, engineering changes or customer projects.
• CAD experience, ideally SolidWorks.
• Experience with Minitab or statistical analysis.
• Strong investigative, analytical and problem-solving skills.

Responsibilities

• Manage and execute equipment and process validation activities.
• Support customer engineering changes and ensure ECNs are implemented within timelines.
• Lead NPI projects, collaborating with customers and internal teams.
• Define and own manufacturing and assembly processes and routings.
• Manage FAIR processes and prepare First Article reports.
• Provide technical support for manufacturing projects.
• Prepare in-house drawings and CAD support.
• Develop tooling and fixtures for production introduction.
• Investigate manufacturing issues and drive process improvements.
• Ensure processes comply with SOPs and quality requirements.
• Collaborate with Engineering, Production, Quality and other functions to deliver objectives.

Skills

Equipment validation

Process validation

NPI

Continuous improvement

Technical problem solving

Cross-functional communication

Analytical thinking

Quality systems

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Minitab

Job description

Morgan McKinley is seeking a Manufacturing Engineer in Waterford to join the engineering team. This role focuses on hands-on manufacturing and assembly processes, equipment validation, NPI, engineering changes and continuous improvement within a regulated environment.

The successful candidate will lead validation activities, support ECNs and NPI projects, and work closely with Engineering, Production and Quality to deliver projects and improve efficiency.