NPI Engineer

Company Pension

Health Insurance

Health Management

Education Reimbursement

Corporate Events

• 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 FM COS 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-ordination to ensure that the necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality in accordance with FM COS Procedures and Regulatory standards.
• 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 FM COS procedures and Regulatory Standards.
• Ensure adherence to risk management requirements by assessment of process risks as appropriate and completion of relevant risk management documentation e.g. PFMEA.
• 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 team work, 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.
• Management of PAO/Trainer/Technician/Associate/NPI Engineers, as applicable (Senior NPI Engineer).

• Required:
• 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) or 5yr+ experience in a product/process technician role in a medical device environment or 10yr+ experience as a technician in an alternative industry where the skillset and experience are considered transferrable.
• Ideally 2-3 years experience in new product introduction, manufacturing, quality or process engineering, preferably in catheter manufacturing.
• Students / Apprentices (unqualified) will be assigned to a fully competent individual. Co-signing will be implemented by the student’s / apprentice’s Manager.
• An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.
• A Senior position may exist for a minimum of 4 years experience.
• 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.