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
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.
Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
Strong proven people management skills – a minimum of 5 years previous experience in a supervisory position leading and motivating a group of talented engineering staff.
Strong interpersonal skills and the ability to communicate across all levels of the organisation.
Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
Proven problem solving skills.
Good computer skills including knowledge of Microsoft® Office.
Excellent organisational and team building skills.
Willingness and availability to travel on company business.