NPI Engineer – Medical Devices: Process & Quality Lead

Freudenberg Group; Carrick-on-Shannon; Presencial; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

Freudenberg Group in Ireland seeks an engineer to drive New Product Introductions for innovative catheter products. You will plan design, process validation, equipment layout, and ensure regulatory alignment.

You will integrate ISO 45001, 14001 and 50001 into development, manage design controls, support clinical trials and documentation, and mentor junior engineers as needed. The role emphasizes manufacturing process optimization and continuous improvement.

Qualificações

• 3+ years of experience in NPI/manufacturing/quality/process engineering
• Experience with catheter manufacturing processes (extrusion, moulding, balloon forming, braiding, packaging, assembly)
• Project management experience in new product introductions, ideally in a medical device environment
• Familiarity with catheter manufacturing processes and related techniques
• Associate position may be available with guidance from experienced engineer for limited experience

Responsabilidades

• Plan and coordinate New Product Introductions (NPIs) across design, process validation and equipment layout
• Integrate ISO 45001, ISO 14001, and ISO 50001 requirements into development
• Ensure robust quality control through testing and process management
• Manage design control activities including verification and validation; support clinical trials and documentation
• Collaborate with the NPI team to develop and optimize manufacturing processes and train staff
• Design efficient manufacturing cells to meet cost, quality, and productivity goals
• Support continuous improvement initiatives including CAPAs and OH&S and Environmental/Energy management
• Provide technical input for quotations and cost estimations during business acquisition
• Senior engineers may mentor Process Operators, Trainers, Technicians, Associates, and NPI Engineers as needed

Conhecimentos

NPI experience

Medical devices

Formação académica

Engineering degree or related field

Descrição da oferta de emprego

Freudenberg Group in Ireland seeks an engineer to drive New Product Introductions for innovative catheter products. You will plan design, process validation, equipment layout, and ensure regulatory alignment.

You will integrate ISO 45001, 14001 and 50001 into development, manage design controls, support clinical trials and documentation, and mentor junior engineers as needed. The role emphasizes manufacturing process optimization and continuous improvement.