New Product Introduction Engineer

Morgan McKinley; Waterford; On-site; EUR 65,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking an NPI Engineer to join a growing engineering team in a highly regulated medical device environment. You will manage projects from feasibility through to manufacturing start-up, qualification and handover to operations.

This hands-on role requires collaboration with Quality, Manufacturing, Engineering, Validation, Supply Chain, Facilities/Maintenance and EHS, plus direct engagement with customer representatives throughout the project lifecycle.

Qualifications

• A Level 8 Bachelor's Honours degree in Engineering or equivalent.
• 3-5+ years' relevant engineering experience, ideally in medical device manufacturing.
• Experience in NPI, project engineering, manufacturing engineering, process development or similar.
• Experience in a regulated manufacturing environment.
• Experience with commissioning and qualification/validation of equipment and/or processes.
• Strong project management skills and ability to manage multiple projects.
• Excellent organisational and communication skills.
• Independent, ownership-driven with hands-on approach.
• Experience in ISO 13485 and medical device manufacturing environments.
• Equipment and process validation experience.

Responsibilities

• Develop and deliver manufacturing processes for new products and projects.
• Manage NPI and engineering projects from concept to start-up and handover.
• Support design for manufacture and transfer of new products to production.
• Develop project plans, scopes of work, cost estimates and quotations.
• Track project costs, schedules, deliverables and progress.
• Coordinate internal and external teams to stay on schedule and within scope.
• Liaise with customers to 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 for equipment and processes.
• Generate work instructions and engineering change documentation.
• Review and approve specifications, drawings and documentation.
• Prepare regular project progress reports for stakeholders.
• Collaborate with cross-functional teams for successful delivery and ownership of decisions.

Skills

NPI

Project engineering

Manufacturing engineering

Process development

Regulated environment

Commission/validation

CAD SolidWorks

MS Project

Excel

SAP/MRP

Education

Bachelor's degree in Engineering (Level 8)

Tools

SolidWorks

MS Project

SAP/MRP

Job description

We are currently recruiting for an NPI Engineer to join a growing engineering team within a highly regulated medical device manufacturing environment.

Reporting to the Lead NPI Engineer, you will play a key role in delivering new product and manufacturing projects, taking projects from initial feasibility through to manufacturing start-up, qualification and final handover to operations.

This is a hands‑on engineering position suited to someone who enjoys working across multiple functions and taking ownership of projects from both a technical and project management perspective.

The Role

As NPI Engineer, you will manage and deliver a range of small to medium‑sized projects, supporting the development and introduction of new manufacturing processes, equipment, tooling and assembly solutions.

You will work closely with internal teams including Quality, Manufacturing, Engineering, Validation, Supply Chain, Facilities/Maintenance and EHS, while also engaging directly with customer representatives throughout the project lifecycle.

Key responsibilities will include:

• Develop and implement manufacturing processes for new products and projects.
• Manage NPI and engineering projects from concept and feasibility through to manufacturing start‑up and handover.
• Support design for manufacture and the 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 ensure projects remain on schedule and within agreed scope.
• Liaise with customers and manage expectations around project progress, scope, timelines and budgets.
• Manage manufacturing, assembly, tooling and fixture design activities.
• Support equipment commissioning and process qualification/validation activities.
• Review and/or approve commissioning and qualification protocols.
• Provide technical support and troubleshooting for equipment and manufacturing processes.
• Generate work instructions, project documentation and engineering change documentation.
• Review and approve relevant specifications, drawings and technical documentation.
• Prepare regular project progress reports and communicate project status to relevant stakeholders.
• Work collaboratively with cross‑functional teams to ensure successful project delivery.
• Take ownership of technical and engineering decisions relating to project delivery.

What We're Looking For

• A Level 8 Bachelor's Honours degree in Engineering or equivalent.
• 3-5+ years' relevant engineering experience, ideally within medical device manufacturing.
• Experience in NPI, project engineering, manufacturing engineering, process development or a similar discipline.
• Experience working within a regulated manufacturing environment.
• Experience with commissioning and qualification/validation of equipment and/or processes.
• Strong project management skills, with the ability to manage multiple projects and challenging timelines.
• Excellent organisational and communication skills.
• The ability to work independently and take ownership of projects and technical issues.
• Strong problem‑solving skills and a practical, hands‑on approach.
• Medical device manufacturing and ISO 13485.
• Pharmaceutical or other highly regulated manufacturing environments.
• Equipment and process validation.
• Manufacturing process development and transfer.
• Tooling and fixture design.
• SolidWorks or another CAD package.
• MS Project and advanced Excel.
• SAP or another MRP system.
• Manufacturing assembly environments.

Why This Role?

This is an excellent opportunity for an engineer looking to take ownership of end‑to‑end NPI and manufacturing projects within a technically demanding and highly regulated environment.

You will have exposure across process development, project management, equipment, tooling, validation, manufacturing and customer engagement, providing the opportunity to develop both your technical and project leadership capabilities.