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Engineering Manager

Reference ID : 773AL
Category :
  • Medical Devices
Date Posted : Mar 7, 2019
Job Location
  • Munster
- Limerick
Experience : 8-10 yrs +
Salary : Neg
Employment Type
Andy Litchfield
Contact Number : +353860482656
Lead a team of Engineers to deliver world class design and manufacturing process of leading medical devices, maintaining device quality, compliance,regulatory approval.

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 Conformance's associated with devices post release to market.
  • Provide engineering input and support to those responsible for Vendor instigated changes.
  • Drive a 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.
  • Equipment transfers \ 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
  • 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.

Qualifications & Requirements

  • Formal production/engineering qualification and/ or 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.

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