NPI Engineer

Freudenberg Group; Carrick-on-Shannon; On-site; EUR 65,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

NPI experience

Medical devices

Education

Engineering degree or related field

Job description

Working at Freudenberg: We will wow your world!

Responsibilities:

As a key member of our team, you'll play a central role in bringing innovative medical products to life. Your responsibilities will include:

• Planning and coordinating New Product Introductions (NPIs), including product design, process validation, equipment layout, and ensuring alignment with regulatory standards.

• Integrating ISO 45001, ISO 14001, and ISO 50001 requirements into product and process development.

• Ensuring robust quality control through testing, equipment evaluation, and process management.

• Managing design control activities, including verification and validation, while supporting clinical trials and technical documentation.

• Collaborating with the NPI team to develop and optimize manufacturing processes, as well as supporting technician and operator training.

• Designing efficient manufacturing cells and workflows to meet cost, quality, and productivity goals.

• Supporting continuous improvement initiatives, including CAPAs, customer complaints, and OH&S, Environmental, and Energy Management systems.

• Contributing to commercial success with technical input for quotations and cost estimations during business acquisition.

• (For Senior Engineers) Managing and mentoring Process Operators, Trainers, Technicians, Associates, and NPI Engineers as needed.

Qualifications:

• Third-level qualification in Polymer, Biomedical, Mechanical, Design Engineering, or a related field. Alternatively, a Bachelor's degree in Science, Technology, Engineering, or equivalent (e.g., Mechanical, Manufacturing, Automation).

• 2-3 years of experience in new product introduction, manufacturing, quality, or process engineering, preferably within catheter manufacturing.

• Project management experience in new product introductions, ideally in a medical device environment.

• Familiarity with manufacturing processes for catheters (e.g., extrusion, moulding, balloon forming, braiding, packaging, and assembly techniques).

• For candidates with limited experience, an Associate position may be available, with guidance from an experienced engineer.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

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