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.

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, 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 Solid Works.

Desired Skills

* Familiarity with setup, calibration, and basic programming of machine vision systems (e.g., Cognex or Keyence)…