Operations Engineering Project Manager

hace 4 semanas

Apodaca, México Celestica A tiempo completo

#128300; Senior Engineering/Operations Manager This position is a senior leadership role, operating at a strategic level by establishing multi-year plans and policies, while also overseeing the tactical execution of engineering and manufacturing operations. 1. #128640; Core Strategic and Managerial Responsibilities The role requires a blend of high-level planning and significant people management authority. Strategic Planning: Establishes three-to-five year plans/objectives and develops policies for the function/unit. Policy & Budget: Establishes and recommends changes to policies. Develops or assists in the development of department budgets and goals Direct & Indirect Supervision: Provides direct supervision to team leaders and professional employees, and indirect supervision through subordinate supervisors. 2. Manufacturing & Operations Management The manager oversees engineering support for production business units, with a heavy emphasis on quality and supply chain. Engineering Oversight: Manages a team providing engineering expertise in support of production business units. Project Management: Manages engineering projects, including defining metrics, resource allocation, budget, schedule management, and contingency planning. Process Optimization: Proven experience optimizing efficiency, yield, and Overall Equipment Effectiveness (OEE) , and implementing Lean and Six Sigma methodologies. 3. #128737;️ Compliance and Regulatory Expertise (Medical Device Focus) A significant part of the role requires in-depth knowledge of regulations specific to the medical device industry. Key Regulations: Strong knowledge and experience with ISO 13485 (Quality Management System for Medical Devices) and FDA 21 CFR Part 820 (Quality System Regulation). Electronic Records: Solid understanding of 21 CFR Part 11 (Electronic Records; Electronic Signatures). Validation: Proficient in IQ/OQ/PQ protocols (Installation, Operational, Performance Qualification) and regulatory compliance. Cleanroom Management: Strong knowledge of Class 7 & Class 8 cleanroom environments and ISO 14644 standards. 4. #127760; Cross-Functional Leadership & Data Management The role requires extensive internal and external collaboration. Collaboration: Builds cross-functional relationships, requiring persuasive skills, negotiation skills, and considerable tact . Interfaces with senior managers and maintains positive relationships with key customers and suppliers . Customer Data Management (CDM): Acts as an internal consultant for CDM application systems and processes, providing integration support to new sites. Strategy & Development: Leads the design and development of global CDM strategies , identifying gaps and leading cross-functional global teams (including consultants and vendors) to develop solutions. #127891; Required Qualifications Education Bachelor's degree in Electronics, Industrial, Mechatronics, Biomedical Engineering, or related field. Advanced studies in Business/Operations/Technology are recommended. Experience Over 8 years of experience in medical and electronic manufacturing. Leadership More than 3 years in a leadership role. Language Advanced English proficiency. Location 100% on-site position.

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