Electro-Mechanical Assembler
BiVACOR
Huntington Beach, CA, USA
USD 28-34 / hour
Posted on Apr 29, 2026
Help Us Build the Future of the Human Heart.
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 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.
Key Responsibilities
BiVACOR offers a competitive compensation package and comprehensive benefits, including:
Apply today and be part of something extraordinary.
BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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 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.
Key Responsibilities
- 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
BiVACOR offers a competitive compensation package and comprehensive benefits, including:
- 401(k) with company matching
- Medical, dental, and vision insurance
- Health Savings Account (HSA) & Flexible Spending Account (FSA)
- Life insurance & Employee Assistance Program
- Generous paid time off
Apply today and be part of something extraordinary.
BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.