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. Ideal 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 #J-18808-Ljbffr