Senior Process Development Engineer

Cook Medical

Clare, Limerick

The primary purpose of this position is to lead a team of Engineers focused on the development of processes required to manufacture device designs which are developed by Research & Development in Cook Medical. Position: Senior Process Development Engineer. Reporting to: Research & Development Manager. Responsibilities: Lead 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. 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. Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role. Work with the R&D Manager and other Senior Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall R&D group. Collaborate with other R&D Teams to ensure the effective completion of all activities associated with an R&D Engineering project / objective. Ensure effective reporting to the R&D Manager. 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. Ensure the effective transfer of products from other Cook 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 to new 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: Drive the Cook Medical compliance culture amongst Manufacturing Engineering team members 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, modify and develop accordingly to further improve operational efficiencies. Designee for Manufacturing Engineering Manager/ R&D Manager and Senior Test Engineer. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Formal Production/Engineering qualification and relevant experience in the area of NPI and/ or process development. Strong proven people management skills. Previous experience in a supervisory position desired. The ability to supervise, lead and motivate a group of talented engineering staff. Proven project management capability in a project leader role. 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. This job originally appeared on RecruitIreland.com.

2796 days ago