Senior Process Development Engineer

Cook Group (Limerick, Ireland) 3 days ago

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

Find out more about Cook Medical here


  • 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.

Senior Process Development Engineer

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