NPI Engineer

freudenberg; Carrick-on-Shannon; On-site; EUR 55,000 - 75,000; Full time

Job summary

Freudenberg Group seeks an engineer to drive New Product Introductions for medical devices, coordinating product design, process validation and manufacturing layout. You’ll align with ISO standards, manage design controls, and support clinical documentation.

Collaborate with the NPI team to optimise processes and train technicians, while contributing to CAPA and OH&S initiatives. Ideally 2–3 years in NPI/manufacturing/quality in a catheter context, with a relevant STEM degree.

Qualifications

• Bachelor-level degree in a STEM field or equivalent (Science/Technology/Engineering).
• 2–3 years in new product introduction, manufacturing, quality or process engineering.
• Experience in catheter manufacturing preferred; familiarity with extrusion, moulding, balloon forming, braiding, packaging and assembly techniques.

Responsibilities

• Plan and coordinate New Product Introductions (NPIs) including product design and process validation.
• Integrate ISO 45001, ISO 14001, and ISO 50001 into product/process development.
• Ensure robust quality control through testing, evaluation and process management.
• Manage design control activities, including verification and validation, plus support clinical trials and documentation.
• Collaborate with NPI team to develop manufacturing processes and train technicians/operators.
• Design efficient manufacturing cells and work-flows to meet cost/quality/productivity goals.
• Support continuous improvement via CAPAs, handling customer complaints, OH&S and energy management.

Skills

NPI planning

Project management

Quality control

Design control

Documentation

Manufacturing processes

Mentoring (senior roles)

Education

Biomedical/Mechanical/Design Engineering degree

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.

VistaMed Ltd.