NPI Engineer

Freudenberg; Carrick-on-Shannon; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Freudenberg Medical Ireland Ltd. seeks an experienced Senior Engineer to lead NPIs, coordinating product design, process validation, equipment layout and regulatory alignment.

You will manage design control activities and support clinical trials and technical documentation in a medical device environment. You will mentor Process Operators and Technicians, drive continuous improvement initiatives, and contribute to quotes and cost estimations during business development.

Qualifications

• Bachelor's degree in Polymer, Biomedical, Mechanical, Design Engineering or related field or an equivalent (e.g., Mechanical, Manufacturing, Automation).
• 2-3 years of experience in new product introduction, manufacturing, quality, or process engineering.
• Experience in medical device or catheter manufacturing is preferred.

Responsabilités

• Plan and coordinate New Product Introductions (NPIs) from design through validation and production readiness.
• Integrate ISO 45001, ISO 14001 and ISO 50001 requirements into product and process development.
• Support design controls, verification and validation, and documentation for clinical trials.

Connaissances

Project management

Quality control

NPI experience

Cross-functional collaboration

Formation

Bachelor's degree in engineering or related field

Description du poste

Working at Freudenberg

We will wow your world! As a key member of our team, you’ll play a central role in bringing innovative medical products to life.

Responsibilities

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. Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. 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 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.