_{15th January, 2026}

Build a device that saves lives.

• Hands-on role assembling, testing and packaging medical devices
• Based onsite in Huntington Beach, CA
• Paying between $28-$34/hr depending on experience

Our client, BiVACOR, are developing breakthrough cardiovascular technology designed to transform the future of heart failure treatment. As a Product Builder / Operator, you won’t just assemble parts, you’ll play a hands-on role in delivering a Class III, life-sustaining medical device to patients who need it most.
If you take pride in precision, thrive in regulated environments, and want your work to truly matter, this is a role where your attention to detail directly impacts patient outcomes.

What the role involves:

Precision Manufacturing & Assembly

• Assemble, inspect, test, and package complex medical devices using detailed work instructions
• Perform delicate, high-precision assembly work, often under microscope or with specialized tools
• Accurately record build and test data in real time using approved documentation
• Identify, escalate, and help resolve quality or process issues early

Quality & Regulatory Compliance

• Work in compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14644, GMP, and GDP
• Complete batch records and device history records with accuracy and discipline
• Immediately report deviations, non-conformances, or equipment issues
• Maintain training certifications and contribute to a strong culture of quality

Operational Excellence & Continuous Improvement

• Suggest and support process improvements to enhance quality, efficiency, and safety
• Participate in training, audits, and new product introduction (NPI) activities
• Collaborate closely with Manufacturing, Quality, and Engineering teams

Operations Support (as needed)

• Assist with inventory handling, receiving, and shipping activities
• Follow proper procedures for material handling and hazardous waste disposal

What We’re Looking For Skills, Competencies & Experience

• 1–2+ years of experience in manufacturing or assembly (medical device highly preferred - or pharma, aerospace, electronics, or other regulated environments)
• Exceptional attention to detail and pride in craftsmanship
• Strong manual dexterity, hand-eye coordination, patience, and steady hands
• Ability to follow detailed written instructions and produce defect-free builds
• Self-motivated, reliable, and comfortable working independently or in a team
• Clear communication skills and strong understanding of written and spoken English
• Commitment to safety, cleanliness, and compliance
• High school diploma or equivalent
• Experience documenting work accurately and consistently

Preferred Experience (Nice to Have)

• Class III medical device or other high-risk product assembly
• Cleanroom manufacturing experience
• Familiarity with FDA QSR, ISO 13485, ISO 14644
• Exposure to process validation (IQ/OQ/PQ) and NPI
• Use of microscopes, precision measurement tools, and test equipment
• Lean Manufacturing or continuous improvement participation

Physical & Work Requirements

• Ability to sit and/or stand for extended periods
• Fine motor skills for detailed assembly tasks
• Ability to lift up to 25 lbs
• Willingness to wear cleanroom attire for full shifts
• Flexibility to work overtime when required

Why Join BiVACOR?

• Be part of a mission-driven team building truly life-saving technology
• Work in a clean, modern, highly regulated manufacturing environment
• Collaborate with engineers and experts at the forefront of cardiovascular innovation - BiVACOR are all about team work!
• Competitive hourly pay with opportunity to grow alongside a rapidly advancing medical technology company
• Full time hours - 8am-5pm (with some flexibility on start/finish times)
• Awesome benefits including PTO vacation time

If this role sounds like you please apply now!

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