Production Manager – Medical Devices

About the role

The company is seeking a bilingual Production Manager to lead its medical device manufacturing operations in Tijuana. The role focuses on driving operational excellence, ensuring regulatory compliance, and delivering production targets.

Key responsibilities

• Lead and develop production teams to meet production targets, quality standards, and operational goals.
• Create, execute, and adjust quarterly, monthly, weekly, and daily production plans aligned with supply chain requirements.
• Drive operational performance through KPI management, including build plan adherence, first‑pass yield, efficiency, uptime, ERP accuracy, and scrap reduction.
• Ensure compliance with ISO 13485, FDA/QSR regulations, safety requirements, and quality system standards, supporting regulatory audits.
• Manage budgets, employee development, continuous‑improvement initiatives, and new product introduction activities.

Required profile

• Bachelor’s degree in Engineering or Business Administration.
• Minimum 5 years of experience in a production management leadership role within a regulated manufacturing environment.
• Bilingual proficiency in English and Spanish (B2+).
• Proven experience with Lean Manufacturing, continuous improvement, and ERP‑based production planning.
• Experience managing budgets, KPIs, and employee performance.

Required skills

• Production planning and scheduling.
• ISO 13485 and FDA/QSR compliance.
• ERP systems and data analysis.
• Lean manufacturing and continuous‑improvement methodologies.
• Budget management and operational KPI tracking.