Manufacturing Engineer

HERO

Job Detail

Location Limerick
Salary Negotiable
Posted
Role Type Permanent
Contact Dominic Courtney
email service@hero.ie

Manufacturing Engineer

Apply Now

Job ID: JOB-12411

Manufacturing Engineer 

Working in Manufacture Engineering is in high demand right now. We’re looking to speak with experienced Manufacturing Engineers keen to work with top global leaders who value their people. This is a great job opportunity in Limerick for a Manufacturing Engineer who enjoys working on innovative projects, values autonomy in their job, and works in a great team.

Reach out and talk with us about this newly created Manufacturing Engineering job opportunity in Limerick to find out more. 


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, systems, or manufacturing processes).
  • The completion of the Investigation / Root Cause Analysis ensures consistency in terms of the methodology used and the outcome achieved.
  • The identification and implementation of appropriate corrective/preventative action, and collaboration with other functions to ensure the same if they are impacted.
  • The verification of the effectiveness of CAPAs.
  • Ensuring that CAPAs are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders.
  • Where Engineering is not the CAPA assignee/process owner work closely with CAPA / Process owners to provide guidance on the items above ensuring a consistent approach and outcome across all functions on site.

Design

  • Identify and undertake projects focused on the successful implementation of:

    • Design changes that will improve existing device quality, performance, and efficacy.
    • 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:

    • Process changes that will improve existing device quality, performance, and efficacy.
    • 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:

    • Code of Conduct.
    • Quality System requirements.
    • Company HR policies.

  • Liaise with internal 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.
  • Experience of 3-5 years working in a medical device environment in a similar role.
  • 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 more information on this Manufacturing Engineer role in Limerick please contact Dominic Courtney at +353 868395533 or email stem@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

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review your data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

 

Dominic Courtney

JOB-12411

Apply Now

Manufacturing Engineer

Dominic Courtney

Role Type Permanent
Contact Dominic Courtney
email service@hero.ie
mobile +086 8395533
linkedIn profile click here

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