Senior Manufacturing Automation Engineer at Beta Bionics in Irvine, CA

Job description

About Beta Bionics 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 Senior Manufacturing Automation Engineer is a technical owner and subject-matter expert for automated and semi-automated manufacturing systems in a regulated medical device production environment. This role leads high-impact automation initiatives that improve safety, quality, throughput, cost, and scalability, while serving as a key technical interface between R&D, Operations, Quality, and equipment suppliers. The position combines hands-on engineering execution with lifecycle, supplier, and validation leadership from early concept through equipment retirement. Essential 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] Equipment Lifecycle Ownership Own assigned manufacturing equipment through concept development, supplier selection, procurement, FAT, SAT, installation, qualification, production release, sustaining support, upgrades, and retirement. Design, Validation, and Documentation Author User Requirements Specifications (URS), equipment acceptance criteria, risk-based test strategies, and supporting technical documentation. Author and execute commissioning, FAT, SAT, IQ, OQ, and PQ protocols and reports, including deviation and discrepancy resolution. Lead or participate in equipment and process design reviews with internal stakeholders and external suppliers. Technical Execution and Troubleshooting Independently design fixtures, nests, adapters, poke-yoke devices, and mechanical improvements that enhance safety, quality, throughput, ergonomics, and reliability. Troubleshoot automation, mechanical, controls, and process issues during equipment debug, pilot builds, production launch, and routine manufacturing. Cross-Functional and Supplier Leadership Serve as the primary technical interface with automation vendors, including RFQ development, technical evaluations, design trade-offs, and supplier oversight. Partner with R&D, Quality, Operations, Maintenance, and automation suppliers to define requirements and ensure equipment meets expectations for fit-for-purpose, maintainability, compliance, and scalability. Sustaining, Compliance, and Continuous Improvement Develop and maintain SOPs, work instructions, PM recommendations, spare parts lists, training materials, and change control documentation. Support root cause analysis, CAPA activities, and continuous improvement initiatives. Ensure equipment, documentation, and validation activities comply with GMP, FDA, and ISO 13485 and internal quality system requirements. Provide technical guidance to engineers, technicians, and cross functional partners as needed. Required Qualifications Bachelor’s degree in Mechanical,