New Product Introduction Engineer

Opto Recruitment; Galway; On-site; EUR 60,000 - 85,000; Full time

Job summary

Opto Recruitment is seeking an NPI Engineer for a leading client based in Galway. The role focuses on developing pilot lines, transitioning manufacturing to a controlled environment, and managing ongoing operations for catheter-based technology products to treat ischemic stroke.

You will drive transfer of manufacturing processes to external partners, lead project plans and proof‑of‑concept studies, collaborate with suppliers, and mentor manufacturing engineers in a fast‑paced medical device

Qualifications

• Bachelor’s degree in Engineering (Materials, Mechanical, Plastics or Biomedical) required.
• SolidWorks or similar required for modelling and analysis of mechanical systems.
• 3 years’ experience in the medical device industry, ideally in manufacturing.

Responsibilities

• Manage the transfer of manufacturing process to external partners and ensure smooth handover.
• Lead training and development of manufacturing/NPI engineers.
• Track and improve internal and external operations metrics to drive efficiency.
• Prepare project plans, specifications and schedules for process and product development.
• Identify and interact with vendors regarding materials, processes and equipment.
• Lead structured problem‑solving activities for product and process challenges.

Skills

Manufacturing knowledge

Problem solving

Project coordination

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Job description

We are hiring a NPI Engineer for one of our leading clients based in Galway.

Job Role and Functional Area

Reporting to the Associate Director of Operations, this role focuses on manufacturing activities, including developing pilot lines, transitioning manufacturing to a controlled environment, and managing ongoing operations.

This work will focus on developing and manufacturing of catheter-based technology products to treat ischemic stroke.

Job Duties and Responsibilities

• Manage the transfer of manufacturing process to external partners.
• Management and training of manufacturing/NPI engineer(s)
• Track and improve internal and external operations metrics.
• Prepare project plans, specifications, and schedules for process and product development.
• Identify and interact with vendors regarding engineering materials, processes, and equipment.
• Lead structured problem-solving activities for product and process challenges.
• Manage the product costs for the internal and external manufactured products.
• Lead the development of new methods of device manufacture.
• Support and manage efforts to verify and validate new processes.
• Commit to ongoing personal development to improve technical and non-technical skillsets.
• Participate in Corrective and Preventive Action activities for design and manufacturing activities, as required
• Responsible for design transfer, process validation and manufacturing activities
• Provide input to supplier selection and evaluation of supplier performance
• Design of fixtures and models for proof-of-concept, and verification/validation testing

Job Qualifications

• Bachelor’s degree or higher in Engineering (Materials, Mechanical, Plastics, or Biomedical)
• Knowledge of relevant manufacturing processes and equipment.
• Experience in modelling and analysis of mechanical systems using SolidWorks or similar
• Ability to rapidly develop device concepts, processes, and fixtures
• 3 years’ experience in the medical device industry, ideally within a manufacturing environment.

Job QMS Training Requirements

This job requires the completion of the internal Quality Management System training as specified in SOP004-3 QMS Training Matrix.