Collins McNicholas

Excellent opportunity for an R&D engineer with experience in the medical device industry to join a developing company in a permanent role based in Leitrim. 

Responsibilities:

  • Development of Products, Processes, and Equipment, including product and material specifications, material sourcing, equipment and tooling specifications and sourcing, process development and testing, to develop new products for customers or the Company from concept to design freeze.
  • Project manage all developments to ensure that all commitments are achieved including functional prototypes, delivery dates, design iteration samples, test protocols and reports, project costs and other project deliverables are achieved.
  • Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation. This will include the completion of Design History Files, Design Inputs, Outputs, Design Reviews, Log books, etc as necessary. Ensure full traceability of Design Development and control of changes.
  • Ensure full and effective transfer of new products after Design Freeze to manufacturing areas ensuring that the product and processes are fully developed to allow product/process validation to begin. Provide comprehensive training to production, quality and technical staff to ensure a smooth production start including validations and records. Note that this stage is to be handles through the official change control (ECR/ECO) procedures.
  • Constantly review the development processes to ensure they are effective and compliant with the goal to achieve the optimum development cycles at minimum cost. Ensure Lean GROWTTH principles are followed especially 3P, 5S, DMAIC and 6 sigma.

Requirements:

  • Third level Qualification in Engineering or Science
  • 2-3 years experience in a similar role
  • Must have experience in the medical device or pharmaceutical industry
  • Ideally, have experience with CAD systems 
  • Excellent team player, communication skills and attention to detail

For further information on this role please contact Mark on 071-9142411 or email mark.whelan@collinsmcnicholas.ie

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