Job Description

Job Summary

The Production Manager – Medical Devices will oversee the day-to-day operations of the manufacturing floor, ensuring production targets, quality standards, and regulatory requirements are met. This role manages assembly line staff, maintains workflow efficiency, supports validations, and enforces FDA cGMP standards in a cleanroom or controlled environment.

Key Responsibilities

• Supervise daily production of medical devices in accordance with SOPs and production schedules
• Ensure compliance with FDA regulations, ISO 13485, and cGMP standards
• Oversee and train line operators, technicians, and support staff
• Coordinate with QA, engineering, and supply chain to manage production flow
• Monitor output metrics: cycle time, yield, defect rate, and downtime
• Implement corrective and preventive actions (CAPA) for production deviations
• Maintain detailed batch records, production logs, and material traceability
• Support validation and scale-up of new product lines or technologies

Qualifications

• Associate degree in Manufacturing Technology, Engineering, or Life Sciences (Bachelor's preferred)
• 3–5 years of experience in medical device, biotech, or clean manufacturing
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and QSR standards
• Strong leadership and organizational skills with hands-on manufacturing experience
• Proficiency with production software, ERP systems, and Excel reporting

Preferred Skills

• Experience with Class I or II medical devices, or cleanroom production
• Six Sigma, Lean, or GMP certification (e.g., ASQ, SME)
• Familiarity with DHRs, lot tracking, and audit documentation
• Bilingual (English/Spanish or English/Mandarin) a plus

Benefits

• Competitive salary and performance bonuses
• Health, dental, and vision insurance
• 401(k) with company match
• Paid time off and holidays
• Career advancement in regulatory, QA, or multi-site operations

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