Tijuana Pacifico Area | Medical Device Company | On- Site position | Medical Device Production Manager The adecuado candidate is a bilingual, hands-on Production Manager with experience leading teams in a regulated manufacturing environment, preferably medical devices. This individual should be highly results-oriented, capable of driving operational excellence through planning, KPI management, Lean initiatives, and compliance while effectively leading people and collaborating across functions.

Top 5 Responsibilities

1. Lead and develop production teams to achieve production targets, quality standards, and operational goals.

2. Create, execute, and adjust production plans (quarterly, monthly, weekly, and daily) in alignment with Supply Chain requirements.

3. Drive operational performance through KPI management, including build plan adherence, first-pass yield, efficiency, uptime, ERP accuracy, and scrap reduction.

4. Ensure compliance with ISO 13485, FDA/QSR regulations, safety requirements, and quality system standards while supporting regulatory audits.

5. Manage budgets, employee development, continuous improvement initiatives, and New Product Introduction (NPI)



activities.

Key Requirements

- Bachelor's degree in Engineering or Business Administration.

- Minimum 5 years of experience in a Production Management leadership role.

- Minimum 5 years of experience in regulated manufacturing environments.

- Bilingual English and Spanish proficiency (B2+).

- Experience with Lean Manufacturing and Continuous Improvement.

- Experience with ERP systems and production planning.

- Experience managing budgets, KPIs, and employee performance.

- Experience with ISO 13485 and FDA/QSR compliance.

Top 5 Hard Skills

1. Production Planning & Scheduling.

2. ISO 13485 / FDA-QSR Compliance.

3. ERP Systems & Data Analysis.

4. Lean Manufacturing & Continuous Improvement.

5. Budget Management and Operational KPI Tracking.

Top 5 Soft Skills

1. Leadership and Team Development.

2. Strategic Thinking with a Hands-on Approach.

3. Strong Communication and Presentation Skills.

4. Problem Solving and Decision Making.

5. Cross-functional Collaboration and Change Management.

📌 Production Manager (Tijuana)
🏢 Vapotherm
📍 Tijuana