NPI Engineer

Responsibilities
• 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 lay-out, production procedures, material specifications, material & packaging procurement in accordance with VistaMed 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 VistaMed 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.
• Students (unqualified) will be assigned to a fully competent individual. Co-signing will be implemented by the student’s Manager.
• 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 etc, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques