NPI Engineer - Med Device Manufacturing & Innovation

Freudenberg; Carrick-on-Shannon; On-site; EUR 60,000 - 90,000; Full time

Job summary

Freudenberg Medical Ireland Ltd. seeks an experienced Senior Engineer to lead NPIs, coordinating product design, process validation, equipment layout and regulatory alignment.

You will manage design control activities and support clinical trials and technical documentation in a medical device environment. You will mentor Process Operators and Technicians, drive continuous improvement initiatives, and contribute to quotes and cost estimations during business development.

Qualifications

• Bachelor's degree in Polymer, Biomedical, Mechanical, Design Engineering or related field or an equivalent (e.g., Mechanical, Manufacturing, Automation).
• 2-3 years of experience in new product introduction, manufacturing, quality, or process engineering.
• Experience in medical device or catheter manufacturing is preferred.

Responsibilities

• Plan and coordinate New Product Introductions (NPIs) from design through validation and production readiness.
• Integrate ISO 45001, ISO 14001 and ISO 50001 requirements into product and process development.
• Support design controls, verification and validation, and documentation for clinical trials.

Skills

Project management

Quality control

NPI experience

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Job description

Freudenberg Medical Ireland Ltd. seeks an experienced Senior Engineer to lead NPIs, coordinating product design, process validation, equipment layout and regulatory alignment.

You will manage design control activities and support clinical trials and technical documentation in a medical device environment. You will mentor Process Operators and Technicians, drive continuous improvement initiatives, and contribute to quotes and cost estimations during business development.