• Sustaining Engineer

    Requisition ID
    2018-5787
    Job Location(s)
    Limerick Ireland
    Travel
    Less than 10%
    Company
    Cook Ireland
    Position Type
    Full Time
    Category
    Engineering
    Education
    Bachelor's Degree
  • Overview

    The primary function of this position is to lead and/or participate in projects focused on design and / or process modifications of devices post release to market, for the purpose of maintaining device quality and compliance, as well as reducing costs and increasing yields.

    Reporting to: Senior Sustaining Engineer  

    Find out more about Cook Medical here

    Responsibilities

    • Lead or participate in engineering projects in any one of the following Sustaining Engineering areas (detailed below) as required - CAPA, Design or Manufacturing.
    • 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 Senior Sustaining Engineers and Sustaining Engineering Manager.
    • Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams.
    • CAPA
    • Lead or participate in engineering projects 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 undertake projects focused on 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 resubmissions 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 undertake projects focused on 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 resubmissions 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 that all activities 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 as required.

    Qualifications

    • Formal production/engineering qualification and relevant experience in at least one of the following areas: Manufacturing Engineering/Device Design & Development/CAPA.
    • Strong project management skills (proven track record of same desirable)
    • Strong interpersonal skills and the ability to communicate across functions.
    • 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.
    • Strong organisational, collaboration, and team building skills.
    • High self-motivation.
    • Willingness and availability to travel on company business.

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