Product Builder​/Operator

The Product Builder / 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).

This role plays a critical part in ensuring each device meets exacting standards before it reaches patients.

This hands-on role contributes to the advancement of BiVACOR's innovative cardiovascular technology, requiring precision and attention to detail.

KEY RESPONSIBILITIES

Manufacturing

• Assemble, repair, inspect and/or test products following instructions.
• Proactively identifies and communicates quality issues and concerns
• Record information on approved documents.
• Dispose of hazardous waste material in the corresponding hazardous waste areas.

Quality Compliance

• 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.

Operational Excellence & Continuous Improvement

• Suggest process improvements to enhance efficiency, quality, and safety.
• Participate in training programs to maintain knowledge of current procedures and regulatory requirements.
• Collaborate effectively with production, quality, and engineering teams

Operations Support

• Perform operations support tasks as required, e.g., receiving, inventory, handling, or shipping

QUALIFICATIONS AND EXPERIENCE

• 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.
• Self-motivated, able to work independently, and take initiative in problem-solving
• 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

Qualifications

• 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.

Preferred

• 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.
• Familiarity with process validation, IQ/OQ/PQ documentation, and NPI (new product introduction)
• 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.

Physical Requirements

• Sit and/or stand for extended periods of time as needed
• Fine motor skills for precise assembly tasks.
• Capability to lift and move up to 25 lbs when needed.
• Willingness to wear cleanroom attire (gown, gloves, mask, etc.) for entire shifts.

BiVACOR is a clinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a next generation life-extending solution.

Headquartered in Huntington Beach, CA and with an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms, PhD and Chief Medical Officer, William Cohn, MD. The original IP was developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia.

Our highly driven and…