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.
Reporting to: Research & Development Manager
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- 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.
- 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.
- 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.