Our Client, a leading Medtech company based in Leitrim, is looking for an NPI Engineer to join their team.
Responsibilities include but are not limited to:
* Leading Projects and Project teams to ensure Project Goals are met, especially on time delivery, quality requirements, and cost targets.
* Planning, implementing, and coordinating New Product Introductions, including product design, specifications, process validations, identification of training needs, process & equipment layout, production procedures, material specifications, and procurement in accordance with the Client's Procedures and Regulatory standards.
* Ensuring the requirements of ISO 45001, ISO 14001, and ISO 50001 are considered during design, development, and new product introduction, and integrated into production processes.
* Sourcing and implementing tooling, equipment, and technologies required for manufacturing new and existing products, coordinating with the Extrusion department as necessary.
* Ensuring effective and comprehensive customer communication throughout the project duration.
* Planning and coordinating necessary testing, evaluation, and control measures to monitor and support product quality in accordance with the Client's Procedures and Regulatory standards.
* Planning and coordinating New Product Design processes, including Design Inputs, Outputs, Verification, Validation, and Technical documentation in accordance with procedures and Regulatory Standards.
* Developing Manufacturing Processes in conjunction with the New Product Introduction Team, including training of technicians and process operators as required.
* Planning and implementing manufacturing cell layouts, workstation design, and material handling to ensure efficient manufacturing to meet product cost, efficiency, and quality targets.
* Leading Project management teams to ensure on-time task completion, effective teamwork, good motivation, and communication.
* Completing tasks within the project scope including validations, testing, and product design.
* Supporting the business acquisition process by completing quotations for piece part prices, equipment, and project costs.
* Providing technical support and customer communication as required.
* Completing other assigned tasks.
* Management of PAO/Trainer/Technician/Associate/NPI Engineers, as applicable (Senior NPI Engineer).
* Adhering to Plant Safety and Health & Safety requirements, ensuring the health and safety of yourself and others.
* Being aware of potential environmental impacts associated with your work and implications of non-conformance.
* Contributing to enhanced energy performance by conserving energy where possible.
* Participating in continual improvement activities of the OH&S, Environmental, and Energy Management systems.
Minimum Qualifications:
* Third level engineering qualification in Polymer, Biomedical, Mechanical, Design; Minimum Bachelor’s Degree in a Science / Technology / Engineering related discipline (Mechanical, Manufacturing, Automation or equivalent).
* Ideally 2-3 years experience in new product introduction, manufacturing, quality or process engineering, preferably in catheter manufacturing.
* An Associate position may exist for candidates with limited experience, assigned to an experienced Engineer.
* Experience in Project Management regarding new product introduction, preferably in a Medical Device environment.
* Preferably highly competent in manufacturing processes used for catheters, including extrusion, moulding, balloon forming, braiding, packaging, and other assembly techniques.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.
Pale Blue Dot Recruitment
The Resource for the MedTech Workforce
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