NPI Engineer: Medical Device Process & Launch Expert

freudenberg; Carrick-on-Shannon; On-site; EUR 55,000 - 75,000; Full time

Job summary

Freudenberg Group seeks an engineer to drive New Product Introductions for medical devices, coordinating product design, process validation and manufacturing layout. You’ll align with ISO standards, manage design controls, and support clinical documentation.

Collaborate with the NPI team to optimise processes and train technicians, while contributing to CAPA and OH&S initiatives. Ideally 2–3 years in NPI/manufacturing/quality in a catheter context, with a relevant STEM degree.

Qualifications

• Bachelor-level degree in a STEM field or equivalent (Science/Technology/Engineering).
• 2–3 years in new product introduction, manufacturing, quality or process engineering.
• Experience in catheter manufacturing preferred; familiarity with extrusion, moulding, balloon forming, braiding, packaging and assembly techniques.

Responsibilities

• Plan and coordinate New Product Introductions (NPIs) including product design and process validation.
• Integrate ISO 45001, ISO 14001, and ISO 50001 into product/process development.
• Ensure robust quality control through testing, evaluation and process management.
• Manage design control activities, including verification and validation, plus support clinical trials and documentation.
• Collaborate with NPI team to develop manufacturing processes and train technicians/operators.
• Design efficient manufacturing cells and work-flows to meet cost/quality/productivity goals.
• Support continuous improvement via CAPAs, handling customer complaints, OH&S and energy management.

Skills

NPI planning

Project management

Quality control

Design control

Documentation

Manufacturing processes

Mentoring (senior roles)

Education

Biomedical/Mechanical/Design Engineering degree

Job description

Freudenberg Group seeks an engineer to drive New Product Introductions for medical devices, coordinating product design, process validation and manufacturing layout. You’ll align with ISO standards, manage design controls, and support clinical documentation.

Collaborate with the NPI team to optimise processes and train technicians, while contributing to CAPA and OH&S initiatives. Ideally 2–3 years in NPI/manufacturing/quality in a catheter context, with a relevant STEM degree.