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!

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Summary/Objective:

Overall responsibility for ensuring reliable operation of production equipment through troubleshooting, maintenance, repair, calibration, and technical support. Collaborates with Production, Engineering, and other departments to minimize downtime, improve processes, and support new product introduction while maintaining regulatory compliance, quality standards, customer satisfaction, and budget requirements.

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]

• Troubleshoot, maintain, repair, calibrate, and rework production equipment and assemblies to ensure reliable operation and minimize downtime.
• Maintain and track accurate records of equipment maintenance, repairs, calibrations, inspections, and troubleshooting activities.
• Collaborate with engineers and cross-functional teams to resolve equipment and process issues, implement improvements, and support new product introduction.
• Maintain thorough knowledge of production processes, equipment, work instructions, and quality requirements.
• Provide technical support to production lines, including equipment issues, changeovers, and production interruptions.
• Perform root cause analysis and implement solutions to prevent recurring equipment, process, and production issues.
• Work independently, prioritize assignments, and make timely decisions based on technical knowledge, analysis, and sound judgment. Ability to work with minimal supervision.
• Manage multiple projects and technical activities while meeting deadlines and adapting to changing priorities.
• Communicate effectively and maintain professional relationships with employees, clients, vendors, and suppliers.
• Complete work accurately and thoroughly while maintaining strong attention to detail, safety, and quality.
• Follow company policies, GMP, FDA regulations, EN ISO 13485 requirements, approved procedures, and applicable quality and safety standards.

Required Education and Experience

Knowledge, Skills & Abilities: **
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• Experience in manufacturing industry, medical device preferred.
• Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs).
• Ability to use basic hand tools such as drills, micrometers, calipers, etc.
• Ability to operate electrical and mechanical equipment and interpret results
• Must be able to read and interpret mechanical drawings and electrical schematics.

Minimum Certifications/Educational Level:

• High School Diploma required.
• Associate degree in a technical field is preferred

Minimum Experience:

• 1–3 years of manufacturing experience, preferably in the medical device or other regulated industries.
• Experience with FDA, ISO 13485, GMP or similar quality systems is preferred.

Work Schedule

• Shift: 3rd Shift
• Scheduled Hours: 5:00 AM – 5:00 PM
• Workdays: Friday, Saturday, and Sunday
• Shift Differential: +7% comp

Location

• This position is based out of our office in Irvine, California 92618

Pay Rate

$25.00+ per hour ****

Work Environment and Personal Protective Equipment

Works in a Lab, Clean Room, and Warehouse environment, within a well-lighted work area with good ventilation and normal noise levels from lab, shop equipment, and clean room. Personal Protective Equipment may be required for laboratory or field work.

****Physical Demands

• While 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. Employee must occasionally lift and/or move up to 40 pounds.
• Wears personal protective equipment as required.
• This position requires travel up to 5% depending upon business needs

Equal Employment Opportunity Statement

It 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.