Descripción y detalle de las actividades
1. Leadership of Line Transfers (Site-to-Site / Line Transfers)
Lead the planning, execution, and completion of manufacturing line transfers between plants (e.g., US → Mexicali), ensuring operational continuity and regulatory compliance.
Define and manage the Transfer Plan: scope, timeline, risks, resources, and success metrics.
Ensure the complete transfer of: Processes (manufacturing, inspection, testing)
Equipment and tooling Documentation (DHF/DHR, BOM, routers, work instructions)
Coordinate Run-at-Rate activities, pilot builds, and ramp-up until target production capacity is reached. Manage risks through FMEA and mitigation plans during the transfer.
Ensure compliance with quality standards during "dual production" or transitional phases.

2. Process Validation Management (IQ/OQ/PQ)Lead the strategy and execution of process and equipment validations in accordance with ISO *****, FDA 21 CFR Part 820, and corporate guidelines.

3. NPI (New Product Introduction) SupportLead the industrialization of new products from the design phase through commercial production. Collaborate with R&D; teams to define and execute: Engineering builds, pilot builds, and process validations. Develop manufacturing capabilities: production lines, fixtures and tooling, and inspection methods. Ensure manufacturing readiness for product launch and ramp-up. Manage engineering change orders (ECOs) during NPI phases.

4. Regulatory Compliance and Quality SystemEnsure that all activities comply with:FDA 21 CFR Part 820 (Design Controls & Process Validation)ISO *****

5. Cross-Functional Team ManagementLead cross-functional teams including:Manufacturing Engineering Quality Engineering R&D; Supply Chain Operations Serve as the central point of communication for transfers and NPI projects.Manage internal and external stakeholders (including suppliers).Develop technical talent and strengthen team capabilities.
Experiencia y requisitos
Required




Manufacturing Engineering Manager background required not Project Manager
Minimum 3 years of direct people management experience within Manufacturing Engineering, including performance management, coaching, employee development and prioritization of engineering resources.
Strong experience supporting sustaining manufacturing in a mid/high-volume complex manufacturing environment.
Strong NPI processes and project execution experience.
Strong product/line transfer experience is mandatory.
Demonstrated ability to lead cross-functional teams across Manufacturing Engineering, Operations, Quality, NPI and other supporting functions.
Demonstrated Mechanical and/or Process Engineering technical capability.
Strong experience in root cause analysis, corrective actions, process improvement and problem solving.
Experience with process/equipment validation and qualification (IQ/OQ/PQ/PPQ).
Demonstrated ownership of manufacturing KPIs such as Yield, Quality, Throughput, Capacity, Scrap/Cost and Equipment Performance.
Demonstrated ability to prioritize multiple competing business needs, drive accountability and deliver results through a team.
Strong communication and escalation skills with the ability to influence across functions and organizational levels.
BS degree in Mechanical Engineering or equivalent engineering discipline.
Medical Device manufacturing experience strongly preferred.

Preferred:
MS degree in an Engineering discipline.
7–8+ years of Manager Manufacturing/Process Engineering experience.
FDA 21 CFR 820 / ISO ***** experience.
Experience with PFMEA, DOE, statistical methods and process capability.
Automation/equipment and fixture development experience.
Experience with Lean Manufacturing and continuous improvement.
Experience taking products/processes through development, validation, launch, transfer and sustaining.

Beneficios
Seguro de vida
Bono anual
Fondo de ahorro
Uniforme
Seguro gastos menores
Seguro gastos mayores
Seguro dental
Ventajas de acuerdo a la LFT
Comedor
Acciones de la compañia

📌 Manufacturing Npi Transfer Manager (Mexicali)
🏢 Intuitive Surgical, S. De R. L De C. V.
📍 Mexicali