End-to-End NPI Engineer — Medical Devices

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

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.