Research and Development Engineer 2, Process Development

• 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.
• Other General Responsibilities:
• 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.

• Bachelor’s degree is required, preferably in engineering or a related field.
• Minimum of 3 years’ relevant experience is desired.
• 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.

• 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

Cook Medical