NPI Engineer

EPM Scientific are currently supporting a leading MedTech client to recruit 2 Project Engineers to join their Cork site on initial 18 month contracts, supporting Cleanroom NPI activities. Both roles are ASAP starts, primarily on site, and paid on a daily rate.

Job description:

• Drive process development, optimization, and cost reduction initiatives across the business units.
• Take full ownership of machine qualifications - from design through to Process Validation.
• Apply structured problem-solving methodologies to identify root causes and implement effective solutions.
• Support new product and process introductions
• Project manage the introduction of new capital equipment, including associated qualification and validation activities.
• Evaluate and optimize process layouts to support new integrations, maximise floor space utilisation, and achieve optimal process flow while upholding product and process quality standards.
• Participate in the selection of components and equipment based on specifications, reliability, and regulatory requirements; collaborate with quality engineers to develop component-specific testing and inspection protocols.
• Contribute to the creation of PFMEA, Control Plans, SOPs, and PPAP documentation for product transfers and launches.
• Conduct Measurement System Analysis (MSA) studies for new products and processes.
• Deliver training and support to manufacturing team members.
• Ensure strict adherence to GMP, safety, and quality procedures.
• Review and approve validation documentation.