NPI Engineer
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What you'll do
- 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.
What they're looking for
- 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).
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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.Company
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