NPI Engineer — End-to-End Medical Device Launch

Morgan McKinley; Munster; On-site; EUR 65,000 - 75,000; Full time

Job summary

Morgan McKinley is seeking a hands-on NPI Engineer in Waterford to lead end-to-end manufacturing projects from feasibility to start-up. You will coordinate with Quality, Manufacturing, Engineering, Validation, Supply Chain, Facilities, and EHS, and engage directly with customers across the project lifecycle.

The role requires a Level 8 Engineering degree and 3–5+ years in NPI or related fields within a regulated medical device environment.

Qualifications

• Level 8 Bachelor's Honours degree in Engineering.
• 3–5+ years' relevant engineering experience, ideally in medical devices.
• Experience in NPI, project engineering, manufacturing engineering, process development or similar discipline.
• Experience working in a regulated manufacturing environment.
• Experience with commissioning and qualification/validation of equipment and/or processes.

Responsibilities

• Develop and implement manufacturing processes for new products and projects.
• Manage NPI and engineering projects from concept through manufacturing start-up and handover.
• Support design for manufacture and transfer of new products into production.
• Develop project plans, scopes of work, cost estimates and quotations.
• Track project costs, schedules, deliverables and overall progress.
• Coordinate internal and external teams to keep projects on schedule and within scope.
• Liaise with customers and manage expectations around progress, scope, timelines and budgets.
• Manage manufacturing, assembly, tooling and fixture design activities.
• Support equipment commissioning and process qualification/validation activities.
• Review and approve commissioning and qualification protocols.
• Provide technical support and troubleshooting for equipment and processes.
• Generate work instructions and project documentation.
• Review and approve relevant specifications, drawings and documentation.
• Prepare regular project progress reports for stakeholders.
• Work with cross-functional teams to ensure successful delivery.
• Take ownership of technical and engineering decisions.

Skills

NPI experience

Project management

Validation

Education

Bachelor's Degree in Engineering (Level 8)

Tools

SolidWorks

MS Project

Excel

SAP / MRP systems

Job description

Morgan McKinley is seeking a hands-on NPI Engineer in Waterford to lead end-to-end manufacturing projects from feasibility to start-up. You will coordinate with Quality, Manufacturing, Engineering, Validation, Supply Chain, Facilities, and EHS, and engage directly with customers across the project lifecycle.

The role requires a Level 8 Engineering degree and 3–5+ years in NPI or related fields within a regulated medical device environment.