Job ID: JOB-11307
NPI Engineer

Commutable from Sligo, Longford, Roscommon

Required Qualifications/Experience/Skills:

• 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.
• Experience in Project Management regarding new product introduction, preferably in a Medical Device environment.
• Preferably highly competent in manufacturing processes used for manufacturing catheters etc., including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.

Duties / Accountabilities (incl. Deputation): This involves but is not limited to:

• Leading Projects and Project teams to ensure Project Goals are met especially on time delivery, quality requirements and cost targets are achieved.
• Planning, implementing and co-ordination of New Product Introductions to include: product design, product specifications, process validations identification of training needs, process & equipment layout, production procedures, material specifications, material & packaging procurement.
• Ensure 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, as required to implement the manufacture of new and existing production. Co-ordinating the supply of extrusions, if required, with the Extrusion department including agreeing specifications of tubing, resins and quality requirements.
• Ensuring effective and comprehensive customer communication throughout the duration of the project.
• Planning and co-ordination to ensure that the necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality.
• Planning and co-ordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design history Files.
• Development of Manufacturing Process in conjunction with New Product Introduction Team including, as required, training of technicians, process operators and other staff.
• Planning and implementing manufacturing cell lay-outs, work station design and material handling to ensure efficient manufacturing to meet product cost targets, efficiency targets and quality targets.
• Leading Project management teams to ensure on-time task completion, effective teamwork, good motivation and effective communication.
• Especially in the area of New Products but also existing products, participation in areas such as Customer Complaints, CAPA’s, etc., either as responsible for timely closure or providing technical support.
• Completing any tasks within the project scope including validations, testing, product design and so forth.
• Supporting the business acquisition process by way of completing quotations for piece part prices, equipment and other project costs. Providing technical support and customer communication as required.
• Completing other tasks as assigned.
• Management of PAO/Trainer/Technician/Associate/NPI Engineers, as applicable (Senior NPI Engineer).
• Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
• Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
• Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc.).
• Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.

For further information on this role please contact Tommy McKeown on 086 0100903 / jobs@hero.ie

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Tommy McKeown

JOB-11307