NPI ENGINEER
We are engaged with a client who is a leading provider of complex extrusions, finished catheters, and devices for the medical device industry, offering expertise in design and manufacturing from concept to final product. Committed to ensuring complete customer satisfaction and staying at the forefront of the healthcare industry, our client continually invests in cutting-edge technologies providing a comprehensive solution for design, manufacture, assembly, sterilization, and distribution of complex medical devices.
Responsibilities
- 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 lay-out, production procedures, material specifications, material & packaging procurement in accordance with company Procedures and Regulatory standards.
- Ensure the requirements of ISO 13485, 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-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 in accordance with company procedures and Regulatory Standards.
- 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.
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.
- 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.
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For a confidential discussion and more information on the role, please contact Davin Ferguson
davin.ferguson@collinsmcnicholas.ie