Manufacturing Engineer II

Duties and Responsibilities Coordination and execution of the Validations and re-validations process (IQ, PC, OQ and PQ). Coordination and execution of opportunity studies. Ensure that production processes meet established quality standards Management of medium-high impact projects/activities Coordination of work teams for project/activity administration Creation and update of pFMEAs, pMVPs Make engineering changes, change evaluations, etc. Fixture design Preparation of Layout of production areas Knowledge in the preparation and maintenance of BOMs, process flow diagrams. Update or correction of manufacturing procedures, product, etc. Perform product design tests Knowledge and management of quality standards, policies and procedures ISO13485, FDA Management and implementation of continuous improvement tools Management, support and monitoring of products in the transfer process Attend internal and external audits of the quality area Experience and requirements Career in Industrial Engineering. 3-5 years Experience in medical products maquiladora Bilingual English/Spanish Skills in lean six sigma tools Use of Minitab, MS Project, MS Excel Technical Knowledge and Skills: Communication and negotiation skills Multifunctional ability and work under pressure Critical thinking Ability to organize resources and establish priorities Ability to assign tasks and responsibilities Basic knowledge of administration Ability to follow procedures Ability to interact, develop and motivate staff Management of basic computer programs (MS Office, Microsoft project, Autocad, Visio, Minitab). Ability to establish and maintain effective working relationships with collaborators from different departments. Ability to work with integrity and build trust. Intermediate problem solving and analytical skills. Ability to critically review and interpret technical documentation. Ability to work precisely with attention to detail. Ability to manage multiple priorities and meet key deadlines under pressure through effective time management skills. Ability to clearly transmit ideas and concepts verbally and in writing (Spanish and English).

Location: Baja California, MX

Posted Date: 4/26/2025