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Engineering Manager

Reference ID : 2072MQ
Category :
  • Medical Devices
Date Posted : Jul 2, 2019
Job Location
:
  • Munster
- Limerick
Experience : 10 Years
Salary : Negotiable - DOE
Employment Type
:
Permanent
Consultant
:
Michael McQuade
Contact Number : 086-0435195
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, and increasing yields.

Principal Responsibilities

Manufacturing Engineering Manager

Headcount Engineering is actively seeking to recruit a Manufacturing Engineering Manager for a leading client’s medical device facility. 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.

Principal Responsibilities:

  • 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.
  • 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 client’s sister companies.
  • Equipment transfers from site 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 are maintained to a high standard as required by Quality Management System.
  • 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.
  • 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.

Qualifications & Requirements

  • 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.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie




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