Senior Process Development Engineer

CPL

Limerick

Senior Process Development Engineer. Reporting to: Research & Development Manager. Responsibilities: • Lead a team of Engineers focused on identification, development, and implementation of new processes required for the manufacture of device designs which are developed by the R&D department. • Ensure that a risk based approach is applied during the development implementation and validation of all processes. • 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. • 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 Company compliance culture amongst Manufacturing Engineering team members and ensure that compliance requirements are always met. • 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. • Delegate for Manufacturing Engineering Manager/ R&D Manager and Senior Test Engineer. Qualifications / Requirements: • Formal Production/Engineering qualification and relevant experience in the area of NPI and/ or process development. • Minimum of 5 years experience. • 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. The Offer: This is a full time/permanent position with an extremely competitive salary with benefits include: • Company sponsored Defined Contribution pension scheme. • Medical Health Insurance cover for you and your immediate family. • Life Assurance and Income Protection cover. • Performance related Bonus. • Fully equipped gym on site. • 39-hour week with flexible start & finish times  Candidates must hold a valid work permit/visa or EU citizenship to be considered. To Apply: If this job sounds ideal to you & you want to enquire in complete confidence or make an application, contact Darren Brown in Cpl Limerick on 087 405 3774 or email your details to darren.brown@cpl.ie.

511 days ago