Engineering Team Leader - Medical Device

Brightwater

Limerick

You willmanage 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. Main Duties: Lead a team of engineers focused on any one of the following areas - 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. 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. 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. 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. The Ideal candidate will have: 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. High self-motivation. Willingness and availability to travel on company business. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2401 days ago