Manufacturing Technician ( Mechanical )
BiVACOR Inc•Huntington Beach, CA
•$28 - $34•Onsite
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
11-50 employees
