• Lead or participate in engineering projects in any one of the following Sustaining Engineering areas (detailed below) as required - CAPA, Design, Manufacturing or NPI.
• 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 Manufacturing Engineering Manager.
• Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory Affairs teams.

• 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.

• 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.

• 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.

• Introduction of new products working with R&D/Process Development
  • Support and/or lead the introduction of new products into CIRL directly from design or transfer from a sister entity.
  • Interact with R&D and Process Development on NPI projects to ensure successful product transfer and implementation.
• Establishing project team and preparing project plans for NPI projects, including the project scope, development of budgets, schedules, and resource requirements.
• Monitoring the progress of projects against agreed plans and managing activities to deliver against agreed goals.
• Conducting project reviews with project team and management, ensuring all concerned are updated on progress.
• Monitoring ongoing project progress and conduct management review upon completion of the project to verify the success of the project against the budget, product cost & schedule and record lessons learned.
• Conducting engineering trials & experiments necessary to verify the process.
• Procuring new equipment required for the product introduction in accordance with company procedures.
• Development & implementation of process controls to assure product quality and cost.

• Ensure that all activities are in compliance with:
  • Cook’s Code of Conduct.
  • Cook’s Quality System requirements.
  • Company HR policies.
• Liaise with other Cook manufacturing facilities as required.

• 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.

About Cook Medical

Since 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As one of the world’s largest private companies, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.

Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.

With a global workforce of over 12,000, we employ over 950 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.

Our employee benefits include:

• Hybrid working - mix of remote & onsite
• Company sponsored Defined Contribution pension scheme
• Medical Health Insurance cover for you and your immediate family
• Life Assurance and Income Protection cover
• Educational Assistance
• Performance related Bonus
• Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
• Fully equipped gym on site
• 39-hour week with flexible start & finish times
• Paid time off to participate in volunteer activities
• Free parking
• Subsidised restaurant
• Sports & Social club