Manufacturing Engineering Manager
Our client a leading company located in Limerick is recruiting for an Engineering Manager to join the team. 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.
- 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 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.
- Ensure the calibration of equipment, calibration documentation and calibration database is maintained to a high standard as required by the 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.
- Team Management:
- Mentoring, coaching and development of direct reports to attain best performance.
- Perform routine appraisals to deliver best results and to obtain the maximum team performance.
- Manage the activities of the Sustaining Engineering team and hold regular team meetings.
- Ensure KPI's and business metrics are achieved.
- Ensure the Sustaining Engineering team are in compliance with the Quality System requirements and Company HR policies.
- Work closely to build effective relationships with Production, Quality and Regulatory teams.
- Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
- Responsible for operating general internal quality systems and documentation.
- Act as a Designee for the Senior Engineering Manager or Team Lead Engineer for change control review as per Quality System Procedures.
- 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.
- Proven problem solving skills.
For further information on this Manager role in Limerick please contact Caroline Kingston on 086 8395531/ firstname.lastname@example.org
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