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Mechanical Engineer

  • Sector: Medical Devices
  • Contact Email: amy.newell@collinsmcnicholas.ie
  • Job Ref: 18629

We are working exclusively with an advanced medical device start up who are looking to begin their production journey. They are looking to hire a permanent Mechanical Engineer to join their team. This role will support the day to day manufacturing of medical devices. The Manufacturing Engineer will facilitate efficient operations across cleanrooms, by assisting with the optimisation of existing processes and implementing new processes, all while ensuring that production goals are met. The Manufacturing Engineer will also provide support to other relevant team members in the company as required.


Responsibilities

The Manufacturing Engineer will assist the larger operations team during the optimisation and scale up of the existing manufacturing processes, this work includes but is not limited to: 

  • Execute equipment, process and product verification and validation testing.
  • Identify and implement changes that will improve the performance and manufacturability of a device.
  • Develop and optimise manufacturing processes.
  • Act as the facilitator for production meetings, problem solving meetings, and improvement events as required.
  • Develop and implement manufacturing training and support Product Builder training on processes & SOPs.
  • Work as part of the operations, quality, and design team to debug and resolve product manufacturing issues.
  • Maintain and produce technical documentation in accordance with Quality System requirements.
  • Purchasing and or sourcing equipment, laboratory supplies, components, devices, and services as required.
  • Participate as a Design Team member in the research, development, and transfer of current and new products to manufacturing, as required.
  • Carry out other tasks as requested

Requirements

  • Level 8 or equivalent qualification in engineering or a related subject
  • Knowledge of quality standards including ISO 13485, MDD, and FDA Requirements
  • Candidate must have a minimum of 2-3 years work experience within the medical device industry. (Experience with class 3 medical device manufacture would be advantageous
  • Experience designing jigs and fixtures for production lines would be advantageous
  • Process development experience would be advantageous
  • Experience in the assembly of medical devices, including bonding.
  • Working knowledge of QMS, GLP requirements.
  • Person must have experience in working to a Quality Management System compliant to ISO 13485.
  • Must have experience with report generation for validation / verification testing.
  • Experience interpreting, following and implementing international standards i.e. ISO, NSAI, ASTM
  • Excellent communication and organisational skills
  • Works effectively in a team environment, and equally as an individual.
  • Good problem-solving ability, and knowledge of applicable problem-solving tools.
  • 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.
  • Working knowledge of Lean/6 sigma principles


For a more detailed and confidential discussion on this role contact Amy Newell.

amy.newell@collinsmcnicholas.ie

091-706718