Senior Manufacturing Automation Engineer

Responsibilities

• Own manufacturing equipment through concept development, procurement, FAT, SAT, installation, and qualification
• Author User Requirements Specifications (URS), acceptance criteria, and risk-based test strategies
• Execute commissioning, FAT, SAT, IQ, OQ, and PQ protocols and reports
• Design fixtures, nests, adapters, and mechanical improvements to enhance safety and throughput
• Troubleshoot automation, mechanical, controls, and process issues
• Serve as the primary technical interface with automation vendors and suppliers
• Develop SOPs, work instructions, and change control documentation
• Ensure compliance with GMP, FDA, and ISO 13485 standards

Requirements

• Bachelor’s degree in Mechanical, Manufacturing, Electrical, or Mechatronics engineering
• 7+ years of experience in automation or manufacturing engineering in a regulated medical device environment
• Experience owning equipment through installation, qualification, and sustaining support
• Proficiency in SolidWorks
• Experience authoring URS and validation protocols
• Ability to read mechanical drawings, electrical schematics, and pneumatic diagrams
• Working knowledge of FDA regulations, GMP, and ISO 13485

Preferred Qualifications

• Experience with machine vision systems (Cognex or Keyence)
• Experience with robotics, servo motion, or PLC/HMI-controlled equipment
• Experience designing fixtures using CAD software

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options with annual company contribution
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

About the Company

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few, through the world’s first bionic pancreas called the iLet.