New Product Introduction Engineer

4 days ago

Galway, Galway, Ireland Pale Blue Dot®Recruitment Limited Full time
New Product Introduction Engineer (Medical Device)

Our Client, a leading Medtech company based in Leitrim, is looking for an NPI Engineer to join their team. Note, a senior position may be considered for a more experienced candidate.

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.
  • 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 required to implement the manufacture of new and existing production.
  • Ensuring effective and comprehensive customer communication throughout the duration of the project.
  • Planning and coordination to ensure that necessary testing, evaluation & control 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 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.
  • 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 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, ensuring 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 reporting accidents, dangerous occurrences, near misses/illness, good catch, and environmental incidents in a timely manner.

Job Requirements

  • 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.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Engineering, Project Management, and Manufacturing

Industries: Medical Equipment Manufacturing and Manufacturing

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