_{03rd March, 2026}

• Help bring BiVACOR’s Total Artificial Heart pump into compliant mechanical production
• Hands-on role supporting precision mechanical assembly, troubleshooting, and validation in a regulated environment
• Onsite in Huntington Beach, CA. $28–$34/hour + benefits
• Manufacturing Technician (Mechanical) – Medical Devices
• Be part of a collaborative team working to deliver this life-saving medical device from development into compliant production - to truly change lives.

BiVACOR is developing a Total Artificial Heart – a breakthrough Class III medical device designed to support patients with advanced heart failure.

We are seeking an experienced Mechanical Manufacturing Technician to join our Huntington Beach team and support the precision assembly of the pump – the most complex and critical component of the device.

This is a hands-on technician role, not a production operator position. You’ll work closely with Engineering, Quality, and Operations to assemble, inspect, test, and troubleshoot complex mechanical systems in a highly regulated environment. This role requires someone comfortable working in production, but with an engineering mindset – understanding how and why systems function, not just following steps.

What you’ll be doing:

• Perform complex mechanical assembly, repair, inspection, and test operations following detailed work instructions
• Build precision sub-assemblies for the artificial heart pump using small hand tools and measurement equipment
• Conduct in-process functional checks and mechanical/electrical verification
• Troubleshoot assembly and equipment issues, supporting root cause investigations and corrective actions
• Support prototype builds, design verification, and validation activities alongside engineers
• Set up, calibrate, and maintain assembly and test equipment
• Complete accurate production documentation including device history records (DHR) in compliance with GMP/FDA standards
• Mentor operators and support continuous improvement initiatives within a cleanroom, regulated manufacturing environment

What we’re looking for:

• 3–7 years’ experience in mechanical assembly, manufacturing, or production within regulated industries (medical device, aerospace, etc.)
• Strong hands-on experience building precision mechanical assemblies (not purely testing or inspection roles)
• Ability to read and interpret engineering drawings and technical documentation
• Experience troubleshooting mechanical build issues and working closely with engineers
• Comfortable working full-time in a production environment with high quality and documentation standards
• Strong attention to detail, manual dexterity, and quality-first mindset

Preferred:

• Experience in Class III medical devices or other high-reliability products
• Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and cleanroom environments
• Exposure to validation activities (IQ/OQ/PQ) or new product introduction

Why BiVACOR?

• Work on a life-sustaining Class III medical device
• Build the core pump - the “heart” of the Artificial Heart program
• Hands-on role with real impact on patient outcomes
• Close collaboration with engineering, quality, and production teams
• Onsite role in Huntington Beach, CA (8:30am–5:00pm)
• Competitive hourly rate with benefits
• Fast growing business with long-term career opportunities
• Be part of a mission-driven team changing the future of cardiac care

If you are ready to bring your mechanical manufacturing expertise to a purpose-driven organization and help build life-saving technology - apply now.

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