NPI Engineer – Medical Device Manufacturing

About the role

As an NPI Engineer at Freudenberg Medical, you will be a key contributor to the development and launch of innovative medical devices. You will work on new product introductions, ensuring that design, process validation, and regulatory compliance are seamlessly integrated.

Key responsibilities

• Plan and coordinate New Product Introductions (NPIs), covering product design, process validation, equipment layout, and regulatory alignment.
• Integrate ISO 45001, ISO 14001, and ISO 50001 requirements into product and process development.
• Ensure robust quality control through testing, equipment evaluation, and process management.
• Manage design control activities, including verification, validation, and support for clinical trials and technical documentation.
• Collaborate with the NPI team to develop and optimise manufacturing processes and support technician/operator training.
• Design efficient manufacturing cells and workflows to meet cost, quality, and productivity targets.
• Support continuous improvement initiatives such as CAPAs, customer complaints, and OH&S, environmental, and energy management systems.
• Provide technical input for quotations and cost estimations during business acquisition.

Required profile

• Third‑level qualification in Polymer, Biomedical, Mechanical, Design Engineering or a related field, or a Bachelor’s degree in Science, Technology, Engineering or equivalent.
• 2‑3 years of experience in new product introduction, manufacturing, quality, or process engineering, preferably in catheter manufacturing.
• Project management experience in new product introductions.

Required skills

• ISO 45001
• ISO 14001
• ISO 50001
• Process validation
• Design control
• Project management

What we offer

• Company pension scheme
• Comprehensive health insurance
• Flexible work models
• Personal development training
• On‑site cafeteria with fresh hot and cold meals