• Collaborate in a team of engineers focused on identification, development, and implementation of new processes (within Cook Medical or with third parties) required for the manufacture of device designs which are developed by R&D in Cook Medical.
• Process validation owner for new processes associated with NPI’s and or process development.
• Ensure that a risk based approach is applied during the development implementation and validation of all processes both within Cook Medical and with third party suppliers.
• Ensuring that the principle of Design for Manufacture is central to the R&D process and the devices developed within R&D.
• Where appropriate apply Lean Manufacturing principles to the design and implementation of new processes.
• Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with NPI’s and or process development.
• Collaborate with other R&D Teams to ensure the effective completion of all activities associated with an R&D Engineering project / objective.
• Work closely to build effective relationships with other functions in particular Operations, Quality and Regulatory teams.
• Supplier selection, process development and validation. Support Regulatory Affairs as required with engineering input for process related submissions and renewals prior to and post initial release of devices to market.
• Ensuring the effective transfer of products from other Cook Medical entities.
• Provide engineering input and support to those responsible for Supplier 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 tonew processes and production lines.
• Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market.
• Support the post market surveillance of devices in terms of complaint investigation and risk analysis.

• Uphold the Cook Medical compliance culture and ensure that compliance requirements are always met.
• Liaise with other Cook manufacturing facilities.
• Support other cross functional groups to achieve Company goals.
• Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

• Formal production/engineering qualification and/or relevant experience in the area of NPI and or process development.
• Ideally candidates should have a minimum of 2 years process development experience in a Medical Device company
• Project management capability
• Strong interpersonal skills and the ability to communicate at all levels of the organisation.
• 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.
• Excellent organisational 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