Production Operator (Mechanical)

BiVACOR Inc•Huntington Beach, CA

6d•$22 - $28

About The Position

At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here. About the Role 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.