NPI Engineer

Freudenberg Medical, LLC; Carrick-on-Shannon; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Company Pension

Health Insurance

Flexible Work Models

Personal Development

Cafeteria/ Canteen

Job summary

Freudenberg Medical, a global CDMO, is seeking an NPI Engineer in Carrick-on-Shannon, Ireland, to lead new product introductions for medical devices. You will drive design, process validation, and equipment layout, ensuring regulatory alignment and robust manufacturability.

Work with cross-functional teams to optimize production cells, apply ISO 45001/14001/50001 concepts, and contribute to technical documentation, cost estimates, and continuous improvement initiatives.

Qualifications

• Third-level qualification in Polymer, Biomedical, Mechanical, Design Engineering, or related field.
• 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).
• An Associate position may be available for candidates with limited experience.

Responsibilities

• Plan and coordinate New Product Introductions (NPIs), including product design, process validation, equipment layout, and ensuring alignment with regulatory standards.
• 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 and validation, while supporting clinical trials and technical documentation.
• Collaborate with the NPI team to develop and optimize manufacturing processes, as well as supporting technician and operator training.
• Design efficient manufacturing cells and workflows to meet cost, quality, and productivity goals.
• Support continuous improvement initiatives, including CAPAs, customer complaints, and OH&S, Environmental, and Energy Management systems.
• Contribute 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.

Skills

Project management

Manufacturing processes

Quality assurance

Process engineering

Education

Polymer/Biomedical/Mechanical/Design Engineering degree

Bachelor's degree in Science/Technology/Engineering

Job description

Working at Freudenberg: \"We will wow your world!\" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

• Company Pension: Save for retirement with the company's help.
• Health Insurance: Rely on comprehensive services whenever you need it.
• Flexible Work Models: We allow for flexible work models to ensure both professional and personal success.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• Cafeteria/ Canteen: We offer fresh food on-site, both hot and cold.

Carrick-on-Shannon (Co. Leitrim)

On-Site

VistaMed Ltd.

You support our team as

NPI Engineer

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.