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Employer Cook Medical
Job Title Engineering Programme Team Leader
Description

The primary function of this position is to manage a team of Engineers focused on design and / or process modifications of devices post release to market.

The primary function of this position is to manage a team of Engineers focused on design and / or process modifications of devices post release to market, for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields.

Reporting to: Sustaining Engineering Manager

Find out more about Cook Medical here

Responsibilities:

  • Lead a team of engineers focused on any one of the following Sustaining Engineering areas (detailed below) as required - CAPA, Design or Manufacturing.
  • Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role.
  • Work with Sustaining Engineering Manager and other Snr. Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall Sustaining Engineering group.
  • Collaborate with other Sustaining Engineering Teams to ensure the effective completion of all activities associated with a Sustaining Engineering project / objective.
  • Ensure effective reporting to the Sustaining Engineering Manager.
  • Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams.
  • CAPA
  • Lead a team of engineers focused on the support / completion of CAPAs (related to design, procedures and systems, or manufacturing processes).
  • The completion of the Investigation / Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved.
  • The identification and implementation of appropriate corrective / preventative action, and collaboration with other functions to ensure same if they are impacted.
  • The verification of effectiveness of CAPA's.
  • Ensuring that CAPA's are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders.
  • Where Engineering are not the CAPA assignee / process owner work closely with CAPA / Process owners to provide guidance on items above ensuring a consistent approach and outcome across all functions on site.
  • Design
  • Identify and guide team in the successful implementation of:
  • o Design changes that will improve existing device quality, performance and efficacy.
  • o Cost reduction and yield/efficiency improvement opportunities.
  • Support Regulatory Affairs as required with engineering input for design related submissions and renewals post initial release of devices to market.
  • Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents.
  • Maintenance of the Risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis).
  • Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
  • Provide engineering support for post market clinical studies if required.
  • Work with CAPA team as required to Root Cause CAPA's and implement changes associated with same.
  • Manufacturing
  • Identify and guide the team in the successful implementation of:
  • o Process changes that will improve existing device quality, performance and efficacy.
  • o Cost reduction and yield/efficiency improvement opportunities.
  • Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market.
  • Support Regulatory Affairs as required with engineering input for process related submissions and renewals post initial release of devices to market.
  • Provide engineering input and support to those responsible for Vendor instigated changes.
  • Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
  • Responsible for process engineering layout plans and implementation in relation to line extensions or redesign.
  • Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
  • Other General Responsibilities
  • Ensure the Sustaining Engineering team are in compliance with:
  • o Cook's Code of Conduct.
  • o Cook's Quality System requirements.
  • o Company HR policies.
  • Liaise with other Cook manufacturing facilities.
  • 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 Manager or Senior Engineer for document review as per Quality System Procedures.
Qualifications/Requirements:

  • Formal production/engineering qualification and relevant experience in at least one of the following areas: Manufacturing Engineering/Device Design & Development /CAPA.
  • Strong proven people management skills. Previous experience in a supervisory position desired. The ability to supervise, lead and motivate a group of talented engineering staff.
  • Strong interpersonal skills and the ability to communicate at 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.
  • High self-motivation.
  • Willingness and availability to travel on company business.

This job originally appeared on RecruitIreland.com
Location Limerick
Date Added 72 days ago
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