Senior Manufacturing Manager

Accordance Search Group; Vista (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Accordance Search Group is seeking a Senior Manufacturing Manager for Vista, CA. The role leads production operations for high-precision, single-use surgical instruments and cutting tools on-site, emphasizing ISO 13485 compliance and lean improvements.

The ideal candidate will be hands-on, with 3–5 years of supervisory experience in medical device manufacturing, strong English/Spanish communication, and a track record of reducing scrap and increasing throughput.

Qualifications

• B.S. degree in Mechanical Engineering, Industrial Engineering, Operations, or related technical discipline.
• Bilingual fluency in English and Spanish (spoken and written).
• 3–5 years of supervisory or management experience in a manufacturing environment, preferably in medical devices.
• Knowledge of safety standards, compliance requirements, and CI/CD tools; ISO 13485 is a plus.
• Certifications: Lean Manufacturing, Six Sigma (Green or Black Belt), or PMP.
• Strong understanding of machinery, plant operations, and supply chain logistics.
• Automation and manual assembly familiarity.

Responsibilities

• Direct daily manufacturing activities to meet production schedules, yield targets, and safety/budget goals across shift teams.
• Lead, mentor, and foster strong bilingual communication across production, assembly, and cleanroom manufacturing teams.
• Ensure strict adherence to FDA cGMP, ISO 13485, and quality system regulations across all manufacturing lines.
• Drive Lean/Six Sigma methodologies to optimize production workflows, reduce scrap rates, and expand throughput capacity.
• Partner with Quality, R&D, Supply Chain, and Process Engineering to introduce new product lines and optimize existing processes.

Skills

Bilingual communication

Lean manufacturing

Leadership

Regulatory awareness

Continuous improvement

Education

B.S. in Mechanical/Industrial Engineering or related

Tools

CI/CD tools

Job description

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/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.
• 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)