Senior Sustaining Engineer

ICDS Recruitment

Limerick

Senior Sustaining Engineer - Limerick. The primary function of this position is to manage a team of engineers focussed 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. Responsibilities: • Lead a team of engineers focussed 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 Senior 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: • Design changes that will improve existing device quality, performance and efficacy. • 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: • Process changes that will improve existing device quality, performance and efficacy. • 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: • Code of Conduct. • Quality System requirements. • Company HR policies. • Liaise with other 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. 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.

2586 days ago