Senior Manufacturing Automation Engineer

Senior Manufacturing Automation EngineerBeta 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 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.Equipment Lifecycle OwnershipOwn assigned manufacturing equipment through concept development, supplier selection, procurement, FAT, SAT, installation, qualification, production release, sustaining support, upgrades, and retirement.Design, Validation, and DocumentationAuthor 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 TroubleshootingIndependently 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 LeadershipServe 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 ImprovementDevelop 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 QualificationsBachelor's degree in Mechanical, Manufacturing, Electrical, Mechatronics, or related engineering discipline.7+ years of experience in automation, equipment engineering, or manufacturing engineering in a regulated medical device or highly regulated manufacturing environment.Demonstrated experience owning manufacturing equipment through installation, qualification, sustaining support, and change management.Experience authoring URS, technical requirements, and validation protocols.Experience with automated or semi-automated assembly, test, or inspection equipment.Ability to read and interpret mechanical drawings, electrical schematics, and pneumatic diagrams.Strong troubleshooting, technical writing, project management, and cross-functional communication skills.Working knowledge of FDA regulations, GMP, ISO 13485, risk management, and change control.Proficiency in SolidWorks.Desired SkillsFamiliarity with setup, calibration, and basic programming of machine vision systems (e.g., Cognex or Keyence) for defect detection, part orientation, and presence/absence verification.Experience designing fixtures or mechanical equipment improvements using CAD software.Experience with robotics, servo motion, pneumatic systems, sensors, or PLC/HMI-controlled equipment.Familiarity with PM development, spare parts strategy, calibration, and long-term equipment lifecycle management.Why You'll Love This RoleYou will own complex and impactful automation in a rapidly scaling medical device manufacturing environment, influence manufacturing and equipment strategy, and see your work directly improve quality of life for people living with diabetes. This role offers end-to-end ownership, meaningful technical challenges, and the opportunity to make a visible impact on critical medical devices.Work Environment and Personal Protective EquipmentThis role operates in a professional office and manufacturing environment. Personal protective equipment may be required for laboratory, cleanroom, or production floor activities.Physical DemandsWhile 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. The employee must occasionally lift and/or move up to 40 pounds. Wears personal protective equipment as required.TravelThis position may require up to 20 percent travel depending upon business needs.LocationThis position is based out of our office in Irvine, California.Salary Range$115,000 - $145,000 - Compensation is commensurate with experience and levelBenefitsComprehensive medical and dental coverageFSA and HSA Plan Options, including an annual company contribution to the HSA401(k) program with employer matchGenerous vacation accrual and paid holiday scheduleEqual Employment Opportunity StatementIt 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.