Manufacturing Technician ( Mechanical )
BiVACOR
Huntington Beach, CA, USA
USD 28-34 / hour
Posted on Mar 4, 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.
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
- 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
- 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
- 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