Senior Manufacturing Automation Engineer

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.

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.

[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]

• Own assigned manufacturing equipment through concept development, supplier selection, procurement, FAT, SAT, installation, qualification, production release, sustaining support, upgrades, and retirement.

• 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.

• 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.

• 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.

• 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.

• Bachelor’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…