Manufacturing Engineer 2

The Manufacturing Engineer 2 will be responsible for key activities across a variety of manufacturing engineering disciplines, namely Process Improvement and Production Support. Key activities will include leading projects to either introduce or support and improve existing products. More specific details are listed below for the specific roles.

Reporting to: Manager, Manufacturing Engineering  

Find out more about Cook Medical here

Process Improvement

• 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 (Supplier Change Notifications).
• 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.
• Participate in engineering projects in any one of the following areas - CAPA, Design, Manufacturing, EHS or NPI.
• Collaborate with other Engineering teams to ensure the effective completion of all activities associated with an Engineering project / objective.
• Ensure effective reporting to the Manager Manufacturing Engineering.
• Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory Affairs teams.
• Lead or participate in engineering tasks focused on the support / completion of CAPAs, process validations and pFMEA activities.
• Support and/or lead the introduction of new products into CIRL directly from design or transfer from a sister entity.
• Support and/or lead Continuous Improvement activities to deliver benefit to key business metrics.
• Development of project deliverables such as BOM’s and Production Documentation (Including IQC and Work instruction creation).

New Product Introduction

• Lead or give direction to process development activities for assigned projects focused on New Product Introduction (NPI).
• Ensure that new products are developed in accordance with DFM principles.
• Ensure that new products/processes integrate with CIRL MFG Operational Unit current and future systems.
  • Lead or technical lead for transfers from Cook sister companies.
  • Accurate definition of Bills of Materials and product capacity requirements.
• Drive project tasks to ensure timely completion of project milestones and business metrics.
• Complete/support retrospective project reviews to understand lessons learned.
• Lead activities that will:
  • Improve device quality, performance, and efficacy.
  • Result in cost reduction and yield/efficiency improvements.
• Work closely to build effective relationships with cross functional groups to achieve project and company goals.
• Collaborate to provide technical expertise across multiple projects or teams in a specific area or subject matter expertise.
• Support Regulatory Affairs as required with engineering technical expertise for design/manufacturing related submissions and renewals post initial release of devices to market.
• Remain on the forefront of emerging industry practices in areas of subject matter expertise.
• Benchmark systems and processes against best industry practice, modify and develop accordingly to further improve operational efficiencies.

Other General Responsibilities

• 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.

• Bachelor’s degree is desired, preferably in engineering or a related field and / or relevant experience.
• Minimum of 3 years’ relevant experience is required.
• Strong interpersonal and organisational skills and the ability to communicate at all levels of the organisation.
• Willingness to seek out and drive improvement.
• Proven project planning skills and the ability to execute projects in a timely and effective manner.
• Team Player with ability to develop strong working relationships.
• Demonstrated problem solving skills. Highly motivated individual, self-starter with a passion for excellence.
• Must be able to work in a fast-paced environment.
• Excellent attention to detail.
• Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820 is preferred.
• High self-motivation, self-starter with a passion for excellence.
• Good working knowledge of Microsoft Office.
• Willingness and availability to travel on company business.

About Cook Limerick  

Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets.   

Our employee benefits include:   

• Hybrid Work Model    
• 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 

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