New Product Introduction Engineer

Opto Recruitment; Galway; On-site; EUR 70,000 - 100,000; Full time

Job summary

Opto Recruitment is seeking an NPI Engineer for a leading client in Galway to drive manufacturing activities including pilot lines, transfers to controlled environments, and ongoing operations.

You will develop and manufacture catheter-based technology products aimed at treating ischemic stroke, while leading transfer, validation, and cost-management efforts with external partners and internal teams.

Qualifications

• Bachelor's degree in Engineering (Materials, Mechanical, Plastics or Biomedical) required.
• Knowledge of relevant manufacturing processes and equipment.
• Experience with modelling and analysis of mechanical systems using SolidWorks or similar.

Responsibilities

• Manage transfer of manufacturing processes to external partners.
• Lead and train manufacturing/NPI engineers.
• Track and improve internal and external operations metrics.
• Prepare project plans, specifications and schedules for process development.
• Interact with vendors on materials, processes and equipment.
• Lead problem-solving activities for product and process challenges.
• Manage product costs for internal and external manufactured products.
• Develop new methods of device manufacture.
• Support verification and validation of new processes.
• Commit to personal development to improve skills.
• Participate in CAPA activities for design and manufacturing as required.
• Design transfer, process validation and manufacturing activities.
• Provide input to supplier selection and evaluation of supplier performance.
• Design fixtures and models for proof-of-concept and testing.

Skills

Manufacturing processes

SolidWorks

Device concept development

Problem solving

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.