Project Engineer

Role Purpose:

• A new opportunity has arisen for a Project Engineer (Design Transfer) to join our client’s new manufacturing site in Co. Kilkenny.
• The Project Engineer will provide the design control expertise to the Kilkenny site.
• You will liaise with global functions to maintain and create change action plans and impact assessments.
• The successful candidate will serve as a technical representative providing design control expertise to product change management teams with potential hands-on involvement in validation activities.

Core Duties and Responsibilities:

• Lead/support completion of Design Control deliverables for design change projects.
• Develops SME level knowledge in the Change Management field, which includes introducing Manufacturing Assessment process to support Change Impact Assessments, Design Transfer Plans and Change Action Plans that impact ADC KKY.
• Own or support the ADC KKY relevant sections of change requests through the full lifecycle, planning, documentation, and approval, including design transfer plans and impact assessments,
• Interface with global functions to ensure alignment on design, process, or documentation changes
• Ensure change control activities are compliant, risk assessed, and effectively communicated to stakeholders
• Prepare high quality technical documents that ensure accuracy, clarity, structure, and compliance with internal template, document control, and regulatory requirements
• Maintain strong DHF/DTF/DMR/BOM documentation as relevant to project scope, and develop good working knowledge of these processes
• Provide regular project updates to stakeholders and leadership
• Partner with/support manufacturing, quality, R&D, and suppliers to resolve technical challenges and ensure robust process performance, when required
• Develop SME level knowledge in the Design Transfer field, which encompasses the lifespan of a product from product commercialization, manufacturing readiness and product launch activities, to mid-life span required changes (e.g. new component introduction, regulatory driven updates, geo-expansions, labelling changes, product specification changes, product rebranding).
• Lead the technical implementation of projects, through defining Success Criteria Matrices, Contingency Planning, Risk Mitigation, Control Phases, Exit Strategy Planning, etc. and working with appropriate staff to understand scope of effort.

Education & Qualifications Required:

• Minimum Level 8 Degree in Manufacturing, Engineering, Science or equivalent in a related discipline.
• A minimum of 3 years of experience working in a similar role in medical device Design Control process, quality engineering, Research and Development, or Process/Manufacturing Engineering with experience supporting product change and development.
• Knowledge and experience of working within the validation lifecycle is also an advantage.

Please note, we do not require agency assistance with this role.