Process Development Engineer

CPL

Limerick

Process Development Engineer. The primary purpose of this position is to focus on the development of processes required to manufacture device designs which are developed by Research & Development team.  Responsibilities: • Collaborate in a team of engineers focused on identification, development, and implementation of new processes  • 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 the company 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 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. Qualifications / Requirements: • Formal production/engineering qualification and/or relevant experience in the area of NPI and or process development. • Ideally candidates should have a minimum of 2 years process development experience in a Medical Device company. • 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. 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.

516 days ago