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Collins McNicholas

Position Title/Job Title Manufacturing Technician

Reporting Structure

This person shall report to the Production Supervisor or designate

Overall Job Objectives

The purpose of this job function is to support the day to day manufacturing of medical devices. This will involve the tasks outlined in the Main Duties and Responsibilities below while playing a supporting role to other team members in the company.    The Manufacturing Technician will work as part of a team to assist in the development and manufacture of innovative medical devices in accordance with the requirements of International Standards: ISO 13485, the FDA Code of Federal Regulations 21 CFR Part 820, Medical Device Directives 93/42/EEC and 2007/47/EC.

Main Duties and Responsibilities

  • Transfer of developed products from R&D to manufacturing.
  • Develop and optimise manufacturing processes and specifications.
  • Develop and implement manufacturing training activities.
  • Execute equipment, process and product verification and validation testing.
  • Identify and implement changes that will improve the performance and manufacturability of a device.
  • Work as part of the operations, quality and design team to debug and resolve product manufacturing issues.
  • Help with the training of Product Builders on processes & SOPs
  • Maintain technical documentation in accordance with Quality System requirements.
  • Maintain equipment, work areas and facilities to ensure a clean and safe work environment and compliance to GLP.
  • Purchasing of equipment, laboratory supplies, components, devices and services as required.
  • Production line set-ups, equipment operation and maintenance, including preventative maintenance.
  • Participate as a Design Team member in the research and development of current and new products, as required.
  • Carry out other tasks as requested

Qualification Required

  • Third level qualification in engineering or a related trade qualification
  • Knowledge of quality standards including ISO 13485, MDD, and FDA Requirements

Work Experience or Training Required

  • Candidate must have a minimum of 3 to 5 years work experience within the medical device industry.
  • Have experience building or sourcing jigs and fixtures for production lines.
  • Have experience in production line set-up.
  • Working knowledge of QMS, GLP requirements.
  • The person must have experience in working to a Quality System compliant to ISO 13485
  • Have experience with report generation for validation/verification testing.

Special Skills Required

  • Excellent communication and organisational skills
  • Works effectively in a team environment
  • Takes ownership of responsibilities and can work autonomously as required
  • Strong working knowledge of Microsoft Office software, Word, Excel, Project etc.
  • Knowledge of clean-room manufacturing processes and methodologies

For a confidential discussion and more information on the role, please contact Christina Nì Dhonnacha on 091706718 or email christina.nidhonnacha@collinsmcnicholas.ie.

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