Senior Sustaining Engineer

Cook Medical

Clare, Limerick

The primary function of this position is to manage a team of Engineers focused on design and / or process modifications of devices post release to market, for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields. Position: Senior Sustaining Engineer. Reporting to: Sustaining Engineering Manager. Responsibilities: Lead a team of engineers focused on any one of the following Sustaining Engineering areas (detailed below) as required - CAPA, Design or Manufacturing. Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role. Work with Sustaining Engineering Manager and other Snr. Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall Sustaining Engineering group. Collaborate with other Sustaining Engineering Teams to ensure the effective completion of all activities associated with a Sustaining Engineering project / objective. Ensure effective reporting to the Sustaining Engineering Manager. Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams. CAPA. Lead a team of engineers focused on the support / completion of CAPAs (related to design, procedures and systems, or manufacturing processes. The completion of the Investigation / Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved. The identification and implementation of appropriate corrective / preventative action, and collaboration with other functions to ensure same if they are impacted. The verification of effectiveness of CAPA’s. Ensuring that CAPA’s are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders. Where Engineering are not the CAPA assignee / process owner work closely with CAPA / Process owners to provide guidance on items above ensuring a consistent approach and outcome across all functions on site. Design. Identify and guide team in the successful implementation of: o Design changes that will improve existing device quality, performance and efficacy. o Cost reduction and yield/efficiency improvement opportunities. Support Regulatory Affairs as required with engineering input for design related submissions and renewals post initial release of devices to market. Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents. Maintenance of the Risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis. Support the post market surveillance of devices in terms of complaint investigation and risk analysis. Provide engineering support for post market clinical studies if required. Work with CAPA team as required to Root Cause CAPA’s and implement changes associated with same. Manufacturing. Identify and guide the team in the successful implementation of: o Process changes that will improve existing device quality, performance and efficacy. o Cost reduction and yield/efficiency improvement opportunities. Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market. Support Regulatory Affairs as required with engineering input for process related submissions and renewals post initial release of devices to market. Provide engineering input and support to those responsible for Vendor 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 line extensions or redesign. Support the post market surveillance of devices in terms of complaint investigation and risk analysis. Other General Responsibilities. Ensure the Sustaining Engineering team are in compliance with: o Cook’s Code of Conduct. o Cook’s Quality System requirements. o Company HR policies. Liaise with other Cook manufacturing facilities. Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies. Responsible for operating general internal quality systems and documentation. Act as a Designee for the Manager or Senior Engineer for document review as per Quality System Procedures. Qualifications/Requirements: Formal production/engineering qualification and relevant experience in at least one of the following areas: Manufacturing Engineering/Device Design & Development /CAPA. 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. 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.

2789 days ago