Senior Manufacturing Manager

Our client is hiring a Senior Manufacturing Manager

• Location
  :
  Vista, CA (On-site
• Industry
  :
  Medical Devices / Ophthalmic & Surgical Instrumentation

We are searching for an experienced, bilingual (English/Spanis
h) Senior Manufacturing Manag
er 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 & Leadersh
  ip:
  Direct daily manufacturing activities to ensure production schedules, yield targets, and safety/budget goals are met across shift teams
• Bilingual Team Communicati
  on:
  Lead, mentor, and foster strong engagement across production, assembly, and cleanroom manufacturing teams through clear bilingual (English/Spanish) communication.
• Quality & Regulatory Complian
  ce:
  Ensure strict adherence to FDA cGMP, ISO 13485, and quality system regulations across all manufacturing lines.
• Continuous Improveme
  nt:
  Drive Lean / Six Sigma methodologies to optimize production workflows, reduce scrap rates, and expand throughput capacity.
• Cross-Functional Collaborati
  on:
  Partner closely with Quality, R&D, Supply Chain, and Process Engineering to introduce new product lines and optimize existing processes.

Qualifications:

• Educati
  on: B.S. degree in Mechanical Engineering, Industrial Engineering, Operations, or a related technical discipline
• Language Proficien
  cy:
  Bilingual fluency in English and Spanish is requi
  red (spoken and written) to lead and collaborate effectively across all levels of manufacturing staff
• Experien
  ce: 3-5 years of supervisory or management experience in a manufacturing enviorment preferably within the medical device industry.
• Regulatory Experti
  se:
  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 Backgrou
  nd:
  Strong understanding of machinery, plant operations, and supply chain logistics.
• Automation and manuel assembly

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)