As an NPI Engineer, you will be at the forefront of innovation, playing a pivotal role in bringing cutting-edge medical devices, particularly catheters, from concept to reality. Your expertise and dedication will directly impact the quality, safety, and success of our clients products. If you are passionate about innovation, quality, and making a difference in healthcare, we invite you to join our clients team and be part of a journey that transforms ideas into life-saving solutions.
- Leading projects and project teams to ensure the achievement of project goals, particularly in terms of on-time delivery, quality standards, and cost targets.
- Planning, implementing, and coordinating new product introductions, including product design, specifications, process validations, training needs identification, process, and equipment layout, production procedures, material specifications, and material/packaging procurement in accordance with our clients Procedures and Regulatory standards.
- Ensuring compliance with ISO 13485, ISO 45001, ISO 14001, and ISO 50001 during design, development, and new product introduction, and integrating them into production processes.
- Sourcing and implementing tooling, equipment, and technologies as needed for new and existing production, including coordinating extrusion supply if necessary.
- Leading project management teams to ensure on-time task completion, effective teamwork, motivation, and communication.
- Participating in areas such as Customer Complaints, CAPA's, etc., either as responsible for timely closure or providing technical support, especially in the context of New Products but also existing products.
- Completing tasks within the project scope, including validations, testing, product design, vendor assessment, and other assigned responsibilities.
- Supporting the business acquisition process by preparing quotations for piece part prices, equipment, and other project costs, and providing necessary technical support and customer communication.
- A third-level engineering qualification in Polymer, Biomedical, Mechanical, Design, or related fields; or
- A minimum of a Bachelors Degree in a Science, Technology, Engineering (Mechanical, Manufacturing, Automation, or equivalent), or a related discipline.
- Alternatively, 5 years or more of experience in a product/process technician role in the medical device industry or 10 years or more of experience as a technician in a different industry with transferable skills and experience.
- Ideally, 2-3 years of experience in new product introduction, manufacturing, quality, or process engineering, with a preference for experience in catheter manufacturing.
- Students without qualifications will work under the guidance of a fully competent individual.
- Co-signing will be implemented by the students Manager.
- An Associate position may be available for candidates with limited experience and will be assigned to an experienced Engineer.
- A Senior position may be considered for candidates with a minimum of 4 years of relevant experience.
- Experience in Project Management related to new product introduction, preferably in the Medical Device industry.
- Preferably, highly competent in manufacturing processes used for catheter production, including extrusion, molding, balloon forming, braiding, packaging, and other assembly techniques.
For further information on this role please contact Danielle Quinn on 086 044 9371 or email@example.com
Check out all our open jobs on our HERO Recruitment website https://www.hero.ie/
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