Production Operator

BiVACOR • Huntington Beach, CA

9h • Onsite

About The Position

This hands-on role contributes to the advancement of BiVACOR’s innovative cardiovascular technology, requiring precision and attention to detail. This role plays a critical part in ensuring each device meets exacting standards before it reaches patients. The Product Operator is responsible for assembling, testing, and packaging medical devices in compliance with documented procedures, quality standards, and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14644).

Requirements

• High school diploma or equivalent.
• Minimum 1–2 years of experience in manufacturing, assembly, or production—preferably in medical devices, pharmaceuticals, or other regulated industries.
• Demonstrated ability to follow detailed instructions and document work accurately.
• Exceptional attention to detail and commitment to product quality.
• Strong focus on safety, cleanliness, and regulatory compliance.
• Ability to work both independently and as part of a team.
• Good communication skills for effective collaboration and reporting.
• Strong manual dexterity and hand-eye coordination, patience and care in handling delicate components.
• Proficiency in communication and understanding of English, including reading work instructions to consistently build defect free medical products

Nice To Haves

• Experience in Class III medical device assembly or other high-risk medical products.
• Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14644 standards.
• Prior use of microscopes, precision measurement tools, and test equipment.
• Experience working in a cleanroom environment.
• Experience with Lean Manufacturing and related principles and working directly with the engineers to make continuous improvement changes.

Responsibilities

• Assemble, repair, inspect and/or test products following instructions.
• Proactively identifies and communicates quality issues and concerns
• Record information on approved documents.
• Dispose hazardous waste material in corresponding hazardous waste areas.
• Maintain training proficiency and certifications to remain in compliance
• Maintain compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Complete production records, batch documentation, and device history records accurately and in real-time.
• Immediately report deviations, non-conformances, or equipment malfunctions to supervisors.
• Maintain a culture of quality and accountability throughout the operations organization.

Benefits

• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off
• A discretionary annual bonus may be available based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED