Process Automation Engineer

Process Automation Engineer Beta Bionics
• Irvine, CA, United States

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.

Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact.

Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team!

Summary/Objective:

The Process Automation Engineer is responsible for developing and maintaining automated systems and tools to support hardware inspection, measurement, and validation processes. This role focuses on ensuring that physical products meet quality standards through the use of automation, sensors, vision systems, and inspection platforms. The ideal candidate has experience in hardware quality control, test equipment automation, and measurement system analysis within a regulated manufacturing environment.

Primary Duties and Responsibilities

[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact]

• Design and implement automated inspection systems for hardware components, assemblies, and final products.
• Integrate vision systems, sensors, and automated fixtures into manufacturing and inspection processes.
• Develop and validate measurement programs for coordinate measuring machines (CMM), optical comparators, and laser scanners.
• Collaborate with Manufacturing Engineering and Quality teams to identify automation opportunities that enhance accuracy, consistency, and throughput.
• Calibrate, maintain, and troubleshoot inspection automation hardware and software.
• Create and maintain documentation for automated test and inspection protocols, reports, and validation results.
• Lead statistical analysis of inspection data, including Gage R&R studies, SPC, and capability analysis.
• Support root cause investigations and corrective/preventive actions for nonconforming materials or products.
• Provide input on the design of fixtures and tooling to ensure inspectability and manufacturability.
• Support incoming, in-process, and final inspection activities using automated solutions.
• Participate in continuous improvement initiatives to optimize inspection workflows and reduce human error.

Required Qualifications

• Knowledge, Skills, & Abilities:
  • Strong knowledge of metrology, measurement systems, and hardware quality control.
  • Proficient in automation tools such as PLCs, Python, or scripting for machine control.
  • Experience with vision systems (e.g., Cognex, Keyence), and data acquisition and analysis.
  • Familiarity with GD&T, mechanical drawings, tolerances, and part specifications.
  • Understanding of quality standards and regulations such as ISO 13485, FDA QSR, and GMP.
  • Excellent analytical, troubleshooting, and documentation skills.
  • Comfortable working in a fast‑paced production and R&D environment.
  • Effective communication and cross‑functional collaboration skills.
• Minimum Certifications/Educational Level:
• Bachelor's Degree in Mechanical, Manufacturing, or Quality Engineering (required).
• 5–8 years of experience in a quality or supplier quality engineering role within a regulated industry (medical device preferred).
• Demonstrated success managing supplier quality systems and…