Sustaining Engineer

HERO

Job Detail

Location Limerick Limerick
Salary Negotiable
Posted
Role Type Permanent
Contact Johanne Kennedy
email choices@hero.ie

Sustaining Engineer

Apply Now

Job ID: JOB-12727
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.

Position: Sustaining Engineer

Reporting to: Senior Sustaining Engineer

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 Company Code of Conduct. o Company Quality System requirements. o Company HR policies.
  • Liaise with other company manufacturing facilities as required.

Qualifications / Requirements:

  • 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.

For further information on this role in Galway please contact Johanne Kennedy on 086 440 3725 / choices@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Johanne Kennedy

JOB-12727

Apply Now

Sustaining Engineer

Johanne Kennedy

Role Type Permanent
Contact Johanne Kennedy
email choices@hero.ie
mobile +353 86 440 37 25
linkedIn profile click here

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