Job Description

The primary function of this position is to manage a team of Engineers focused on supporting the design and manufacturing process of devices post release to market, for the purpose of maintaining device quality, compliance, securing regulatory approval, as well as reducing costs and increasing yields.

Reporting to: Senior Manager Post Market & Manufacturing Engineering

  • Identify cost reduction and yield/efficiency improvement opportunities (process design) and guide team in the successful implementation of same on existing devices.
  • Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market.
  • Provide engineering input and support to those responsible for Vendor instigated changes.

  • Drive the Cook Medical compliance culture amongst Manufacturing Engineering team members and ensure that compliance requirements are always met.

  • Responsible for process engineering layout plans and implementation in relation to line extensions or redesign.

  • Responsible for Line support: production support and maintenance activities. Product transfers from Cook sister companies.

  • Equipment transfers from Cook sister companies \ new technology sourcing and introduction

  • Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.

  • Provide guidance on designing and Developing Jigs and Fixtures for Manufacturing and Product Development.

  • Oversee equipment design and the application of machine controls to production equipment.

  • Ensure the calibration of equipment, calibration documentation and calibration database is maintained to a high standard as required by Cook Quality Management System.

  • Manage all occurrence of out of Calibration equipment.

  • Maintenance of those elements of the Risk management file for existing devices, for which engineering is responsible, including for example dFMEA, pFMEA, Risk Benefit Analysis.

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