Senior Manufacturing Manager

Our client is hiring a Senior Manufacturing Manager

• Location: Vista, CA (On-site
• Industry: Medical Devices / Ophthalmic & Surgical Instrumentation
• Language Requirement: Bilingual (English & Spanish)

We are searching for an experienced, bilingual (English/Spanish) Senior Manufacturing Manager to lead production operations for high-precision, single-use surgical instruments and cutting tools in Vista, CA. If you are a hands-on operations leader with a strong track record in medical device manufacturing, ISO 13485 compliance, cleanroom management, and driving lean manufacturing improvements—while effectively communicating across diverse, Spanish-speaking production teams—we want to hear from you!

Key Responsibilities:

• Production Operations & Leadership: Direct daily manufacturing activities to ensure production schedules, yield targets, and safety/budget goals are met across shift teams
• Bilingual Team Communication: Lead, mentor, and foster strong engagement across production, assembly, and cleanroom manufacturing teams through clear bilingual (English/Spanish) communication.
• Quality & Regulatory Compliance: Ensure strict adherence to FDA cGMP, ISO 13485, and quality system regulations across all manufacturing lines.
• Continuous Improvement: Drive Lean / Six Sigma methodologies to optimize production workflows, reduce scrap rates, and expand throughput capacity.
• Cross-Functional Collaboration: Partner closely with Quality, R&D, Supply Chain, and Process Engineering to introduce new product lines and optimize existing processes.

Qualifications:

• Education: B.S. degree in Mechanical Engineering, Industrial Engineering, Operations, or a related technical discipline
• Language Proficiency: Bilingual fluency in English and Spanish is required (spoken and written) to lead and collaborate effectively across all levels of manufacturing staff
• Experience: 3-5 years of supervisory or management experience in a manufacturing enviorment preferably within the medical device industry.
• Regulatory Expertise: Knowledge of safety standards, compliance requirements, and CI/CD tools. Medical Device Regulations- ISO 13485 is a plus.
• Certifications: Lean Manufacturing, Six Sigma (Green or Black Belt), or Project Management (PMP)
• Technical Background: Strong understanding of machinery, plant operations, and supply chain logistics.

Work Environment:

• Automation and manuel assembly
• 3 shift operation
• Servant Leadership approach

Key Performance Indicators (KPIs)

• Productivity and Quality
• Machine/System uptime and reliability.
• Automation adoption rate and efficiency gains.
• Overall Equipment Effectiveness (OEE)
• Cycle time reduction and production throughput
• Cost reduction (operational and material cost)