Medical Device Production Manager

We are a medical device company in the Pacific region seeking a Production Manager with at least 5 years of leadership experience in regulated manufacturing environments, preferably in the medical device industry. Bilingual English and Spanish (B2+) proficiency, strong experience in production planning, ERP systems, Lean Manufacturing, continuous improvement, KPI management, and budget administration.

Responsibilities

- Lead production operations and manage teams of assemblers and supervisors to achieve production plans and quality objectives.
- Develop and execute quarterly, monthly, weekly, and daily production plans in alignment with Supply Chain requirements.
- Monitor and drive key operational metrics, including build plan adherence, first-pass yield, operator efficiency, uptime, ERP transaction accuracy, and scrap reduction.
- Ensure compliance with ISO 13485, FDA/QSR regulations, safety requirements, and quality system standards while representing Production during audits.
- Manage departmental budgets, support continuous improvement initiatives, and lead production-related activities for New Product Introductions (NPI).

Hard Skills

- Production Management and Manufacturing Planning.
- ISO 13485, FDA/QSR,



and regulated manufacturing environments.
- ERP/MRP systems and data-driven decision making.
- Lean Manufacturing and Continuous Improvement methodologies.
- Budget management, operational reporting, and KPI analysis.

Soft Skills

- Leadership and team development.
- Strong bilingual communication skills (English and Spanish, B2+).
- Strategic thinking with a hands‑on management approach.
- Problem-solving and data-driven decision making.
- Cross-functional collaboration and project management.

Adecuado Candidate Profile

- 5+ years of leadership experience in a production management role.
- Experience in regulated manufacturing environments, preferably medical devices.
- Proven ability to create and execute production plans with a high level of accuracy.
- Strong background in Lean Manufacturing and continuous improvement initiatives.
- Experience managing budgets, KPIs, ERP systems, and employee development.
- Bilingual English and Spanish proficiency at a B2 level or higher.

Location & Hours

City: Tijuana

Shift: Monday–Friday 7:00‑17:00, Saturday 7:00‑15:00

Languages: English (80%)

Visa: Sentri

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📌 Production Manager (Tijuana)
🏢 Tacna Services
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