Job Description
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, product specifications, process validations, identification of training needs, process & equipment layout, production procedures, material specifications, and material & packaging 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 as required to implement the manufacture of new and existing production. Coordinating the supply of extrusions 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 coordination to ensure that necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality in accordance with the Procedures and Regulatory standards of the Client.Planning and coordinating 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 in accordance with procedures and Regulatory Standards of the Client.Development of Manufacturing Process in conjunction with the New Product Introduction Team, including training of technicians, process operators, and other staff 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 effective communication, especially in the area of New Products, but also existing products, participation in areas such as Customer Complaints, CAPA’s, etc.Completing any tasks within the project scope, including validations, testing, product design, and so forth.Supporting the business acquisition process by 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).Adhering to Plant Safety requirements and Health & Safety requirements relating to your work, ensuring the health and safety of yourself and others.Being aware of the potential environmental impacts associated with your work and the implications of non-conformance.Contributing to enhanced energy performance by conserving energy where possible (Lighting, Equipment, Air Conditioning, etc).Contributing to the continual improvement activities of the OH&S, Environmental, and Energy Management systems through participation, providing feedback/suggestions for improvement, and reporting accidents, dangerous occurrences, near misses/illness, good catches, and environmental incidents in a timely manner.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 where there is limited experience and will be 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 manufacturing 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 RecruitmentThe Resource for the MedTech Workforce #J-18808-Ljbffr