Production Operator

About the Company

BiVACOR is developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world.

Responsibilities

• Assemble, repair, inspect and/or test products following instructions
• Proactively identify and communicate quality issues and concerns
• Record information on approved documents
• Dispose of 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
• Report deviations, non-conformances, or equipment malfunctions to supervisors

Requirements

• High school diploma or equivalent
• 1–2 years of experience in manufacturing, assembly, or production
• Experience in regulated industries such as medical devices or pharmaceuticals
• Strong manual dexterity and hand-eye coordination
• Proficiency in English for reading work instructions
• Ability to follow detailed instructions and document work accurately

Preferred Qualifications

• Experience in Class III medical device assembly
• Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14644 standards
• Experience with microscopes, precision measurement tools, and test equipment
• Experience working in a cleanroom environment
• Experience with Lean Manufacturing principles

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