Operations Engineering Manager

hace 2 semanas

Apodaca, México Celestica A tiempo completo

Senior Engineering/Operations ManagerThis 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. Core Strategic and Managerial ResponsibilitiesThe 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 goalsDirect & Indirect Supervision: Provides direct supervision to team leaders and professional employees, and indirect supervision through subordinate supervisors.2. Manufacturing & Operations ManagementThe 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. ️ 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. Cross-Functional Leadership & Data ManagementThe 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. Required QualificationsEducationBachelor's degree in Electronics, Industrial, Mechatronics, Biomedical Engineering, or related field. Advanced studies in Business/Operations/Technology are recommended.ExperienceOver 8 years of experience in medical and electronic manufacturing.LeadershipMore than 3 years in a leadership role.LanguageAdvanced English proficiency.Location100% on-site position.

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