NPI Engineer – Medical Devices (Flexible Work)

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

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.