New Product Introduction Engineer

Morgan McKinley; Waterford; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Permanent position

Career development opportunities

Job summary

Morgan McKinley is seeking an NPI Engineer to join an established engineering team in a medical device manufacturing environment in Ireland. You will contribute to new product introduction projects, developing manufacturing processes, and supporting transfer of products into production.

Working with Manufacturing, Quality, Validation and Supply Chain, you will oversee feasibility studies, process development, equipment commissioning, qualification and handover, ensuring quality and regulatory

Qualifications

• Engineering or technical discipline degree required.
• 3–5 years’ experience in NPI, manufacturing or project engineering.
• Experience in medical device, pharmaceutical or regulated environments.
• Exposure to commissioning, qualification or process validation.
• Strong problem-solving and cross-functional collaboration skills.

Responsibilities

• Support NPI projects from feasibility to start-up and handover.
• Develop and optimise manufacturing processes for new products.
• Coordinate activities across Manufacturing, Quality, Validation and Supply Chain.
• Assist with equipment introduction, tooling and fixture development.
• Prepare project plans, technical docs and change records.
• Support validation activities and qualification protocols.
• Monitor progress against schedules, escalating risks when needed.
• Resolve technical issues with suppliers and internal stakeholders.

Skills

Problem solving

Cross-functional collaboration

Project coordination

Communication

Education

Engineering degree

Tools

SolidWorks

CAD software

Microsoft Project

Excel

SAP/MRP

Job description

Medical Device Manufacturing | Ireland | Permanent

The Opportunity

We are seeking an NPI Engineer to join an established engineering team within a medical device manufacturing environment. This is an opportunity for an engineer with approximately 3–5 years’ relevant experience to contribute to new product introduction projects, developing manufacturing processes and supporting the successful transfer of products into production.

Working closely with Engineering, Manufacturing, Quality, Validation and Supply Chain teams, you will support projects from initial feasibility and process development through equipment commissioning, qualification and manufacturing handover.

Key Responsibilities

• Support NPI projects from initial feasibility and process development through to manufacturing start-up and handover.
• Develop, implement and optimise manufacturing processes for new products and product changes.
• Coordinate engineering activities across Manufacturing, Quality, Validation, Supply Chain, Facilities and other relevant functions.
• Support the design for manufacture (DFM) process, identifying opportunities to improve manufacturability, efficiency and quality.
• Assist with equipment introduction, tooling and fixture development, commissioning and qualification activities.
• Prepare and maintain project plans, technical documentation, work instructions and engineering change records.
• Support equipment and process validation, including the review and execution of relevant qualification protocols.
• Monitor project progress against agreed schedules, deliverables and cost expectations, escalating risks or delays where necessary.
• Liaise with suppliers and internal stakeholders to resolve technical issues and ensure project requirements are met.
• Troubleshoot manufacturing and process issues, contributing to root cause investigations and continuous improvement initiatives.
• Ensure engineering activities comply with applicable quality, safety and regulatory requirements.

Requirements

• A degree in Engineering or a relevant technical discipline.
• Approximately 3–5 years’ experience in NPI, manufacturing engineering, process engineering or project engineering.
• Experience working within medical device, pharmaceutical or another regulated manufacturing environment.
• Understanding of manufacturing process development, equipment introduction and production transfer.
• Exposure to commissioning, equipment qualification or process validation.
• Strong problem-solving skills, with the ability to investigate technical issues and implement practical solutions.
• Experience working cross-functionally with Engineering, Manufacturing, Quality and other stakeholders.
• Good communication, organisation and project coordination skills.
• Ability to manage competing priorities and work effectively within a project-based environment.
• Knowledge of ISO 13485, GMP or similar quality management requirements.
• Experience with IQ/OQ/PQ, FAT/SAT or other equipment and process qualification activities.
• Exposure to tooling, fixtures, assembly processes or automated manufacturing equipment.
• Familiarity with SolidWorks or other CAD software.
• Experience using Microsoft Project, Excel or SAP/MRP systems.

What’s on Offer?

• An opportunity to develop your NPI and project engineering experience within medical device manufacturing.
• Exposure to new product introduction projects and cross-functional engineering teams.
• The opportunity to build your experience across process development, equipment qualification and manufacturing start-up.
• A permanent position with scope to develop your technical and project delivery capabilities.