Senior Manufacturing Test Engineer
Beta Bionics, Inc.•Irvine, CA
•$110,000 - $135,000•Onsite
About The Position
The Senior Manufacturing Test Engineer leads the development, implementation, and optimization of manufacturing test processes and advanced automated test systems. This role ensures product quality and reliability by designing robust test methods, developing scalable software-driven solutions, and owning the full equipment validation lifecycle, including in-house Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and IQ/OQ/PQ. The role also drives technical leadership, standardization, and continuous improvement across manufacturing operations.
Requirements
- Bachelor’s (Master’s preferred) in Electrical, Mechanical, Biomedical, Computer Engineering, or related field
- 5–8+ years of experience in manufacturing test engineering
- Advanced experience with Python programming (test automation, data analysis, equipment control)
- Strong experience leading in-house FAT/SAT and validation (IQ/OQ/PQ)
- Deep knowledge of test equipment and systems (DAQ, sensors, PLCs, automation)
- Strong problem-solving and root cause analysis skills (5 Whys, Fishbone, DOE)
Nice To Haves
- Experience designing custom automated equipment and test platforms
- Strong data analytics and visualization skills (Python, SQL, Pandas)
- Experience with MES systems and digital manufacturing integration
- Medical device or highly regulated industry experience
- Lean / Six Sigma certification (Black Belt preferred)
Responsibilities
- Lead design, development, and validation of manufacturing test methods, fixtures, and complex automated test systems
- Architect, develop, and maintain scalable test software using Python for data acquisition, execution, and analysis
- Integrate test hardware with software platforms (DAQ systems, sensors, PLCs) and ensure system-level performance
- Drive test automation, data integrity, and system standardization across manufacturing lines
- Define and lead test strategy for new product introduction (NPI) and scale to production
- Own and lead in-house Factory Acceptance Testing (FAT) to verify equipment functionality and performance
- Lead Site Acceptance Testing (SAT), installation, and commissioning activities
- Define and drive full validation lifecycle (IQ/OQ/PQ) including protocol development and execution
- Troubleshoot complex system-level issues across hardware, software, and processes
- Analyze large datasets using Python, SQL, or similar tools to drive yield improvement and cost reduction
- Collaborate and lead cross-functional technical discussions with R&D, Quality, Manufacturing, and leadership
- Develop and maintain test documentation, software scripts, FAT/SAT protocols, and validation reports
- Ensure compliance with regulatory standards (FDA, ISO 13485, GMP)
- Mentor junior engineers and technicians
- Lead continuous improvement initiatives and test automation roadmap development
Benefits
- Comprehensive medical and dental coverage
- FSA and HSA Plan Options, including an annual company contribution to the HSA
- 401(k) program with employer match
- Generous vacation accrual and paid holiday schedule
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
