Process Automation 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.

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).
• Minimum Experience:
  • 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 corrective actions.

SCOPE

• Collaborate with cross-functional teams on supplier selection, qualification, and performance improvement.
• Support NPI and sustaining activities with a focus on supplier component readiness and compliance.
• Maintain a database of approved suppliers and quality performance metrics.
• Act as a liaison between the company and suppliers for quality-related matters.
• Work with Manufacturing Engineering to resolve component issues and support continuous improvement.

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 30 pounds.
• Wears personal protective equipment as required.
• This position requires up to ten (10%) percent travel.

Location

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

Salary Range

$110,000 - $130,000

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.