You will 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.
• 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 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 sister companies.
• Equipment transfers from 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.
o Mentoring, coaching and development of direct reports to attain best performance.
o Perform routine appraisals to deliver best results and to obtain the maximum team performance.
o Manage the activities of the Sustaining Engineering team and hold regular team meetings.
o Ensure KPI’s and business metrics are achieved.
o Ensure the Sustaining Engineering team are in compliance with Quality System requirements and
• Formal production/engineering qualification and relevant experience in both manufacturing engineering and/or device development.
• 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.
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255