New Product Introduction Engineer

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

NPI Engineer

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Location: Waterford

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Employment Type: Permanent

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Sector: Medical Device Manufacturing

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

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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.

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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.

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The Role

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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.

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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.

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Key responsibilities will include:

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• 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.
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• Manage manufacturing, assembly, tooling and fixture design activities.
\
• Support equipment commissioning and process qualification/validation activities.
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• Review and/or approve commissioning and qualification protocols.
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• Provide technical support and troubleshooting for equipment and manufacturing processes.
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• Generate work instructions, project documentation and engineering change documentation.
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• Review and approve relevant specifications, drawings and technical documentation.
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• Prepare regular project progress reports and communicate project status to relevant stakeholders.
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• Work collaboratively with cross‑functional teams to ensure successful project delivery.
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• Take ownership of technical and engineering decisions relating to project delivery.
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What We're Looking For

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• A Level 8 Bachelor's Honours degree in Engineering or equivalent.
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• 3–5+ years' relevant engineering experience, ideally within medical device manufacturing.
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• Experience in NPI, project engineering, manufacturing engineering, process development or a similar discipline.
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• Experience working within a regulated manufacturing environment.
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• Experience with commissioning and qualification/validation of equipment and/or processes.
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• Strong project management skills, with the ability to manage multiple projects and challenging timelines.
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• Excellent organisational and communication skills.
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• The ability to work independently and take ownership of projects and technical issues.
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• Strong problem‑solving skills and a practical, hands‑on approach.
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Desirable Experience

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• Medical device manufacturing and ISO 13485.
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• Pharmaceutical or other highly regulated manufacturing environments.
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• Equipment and process validation.
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• Manufacturing process development and transfer.
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• Tooling and fixture design.
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• SolidWorks or another CAD package.
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• MS Project and advanced Excel.
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• SAP or another MRP system.
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• Manufacturing assembly environments.
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Why This Role?

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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.

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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.