Senior Manufacturing Test Engineer

Senior Manufacturing Test Engineer

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions – and a better life for those living with diabetes – with the world's first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user's weight – the iLet does the rest. The iLet lets users "Go Bionic" with their diabetes management. *User must be carb aware.

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.

Primary Duties and 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

Required Qualifications

• 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)

Preferred Qualifications

• 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)

Key Competencies

• Technical leadership and system-level thinking
• Strong software + hardware integration expertise
• Ownership of full validation lifecycle (FAT → SAT → IQ/OQ/PQ)
• Hands-on troubleshooting across hardware and software systems
• Strategic mindset with strong execution capability
• Excellent cross-functional communication and leadership skills

Work Environment and Personal Protective Equipment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners.
• Personal Protective Equipment may be required for laboratory or field work.

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear.
• Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
• Employee must occasionally lift and/or move up to 50 pounds.
• Wears personal protective equipment as required.
• This position requires up to five (5%) percent travel.

Location

• This position is based out of our office in Irvine, California.

Salary Range

$110,000 - $135,000

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

Equal Employment Opportunity Statement

It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.