Assembler I

Beta Bionics, Inc.; Irvine (CA); On-site; USD 38,000 - 52,000; Full time

Job summary

Join a mission-driven company dedicated to revolutionizing diabetes management with the world's first bionic pancreas. As an Assembler I, you'll play a crucial role in assembling and packaging innovative medical devices in a collaborative environment. You'll work alongside experienced professionals and have the opportunity to make a significant impact on the lives of those living with diabetes. If you have a passion for quality and detail, and you thrive in a dynamic setting, this role offers a unique chance to contribute to groundbreaking technology while advancing your career in the medical device field.

Qualifications

• 2+ years in a medical device environment preferred.
• Experience in FDA/GMP/ISO environment preferred.

Responsibilities

• Perform electro-mechanical and clean room device assembly.
• Comply with FDA regulations and company SOPs.

Skills

Manual hand assembly skills

Attention to detail

Teamwork

Communication skills

Ability to learn new equipment

Education

Experience in FDA/GMP/ISO environment

2+ years in a medical device environment

Job description

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.

Beta Bionics is a public benefit corporation. This means we are a for-profit company with obligations to serve both our public benefit mission and shareholders' interests. Beta Bionics is also a certified B Corporation; and as such accountable to operate with high standards of transparency, sustainability and accountability to our customers, employees, business partners, society, and the environment.

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 Assembler I will perform duties associated with electro-mechanical and clean room device assembly and packaging. The critical attributes and skills required for this position include manual hand assembly skills, attention to detail, initiative, working well within a team, and ability to produce consistently high-quality results.

Essential Duties and Responsibilities

• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations including compliance to EN ISO 13485, Medical Device Quality Standards.
• Comply with company Standard Operating Procedures (SOPs) and departmental policies and procedures (DOPs), objectives, the quality assurance program, as well as safety and environmental standards.
• Ability to establish, build and maintain professional working relationships with all levels of staff, clients, and suppliers.
• Excellent interpersonal, verbal, and written communication skills. Meticulous attention to detail and meeting deadlines.
• Ability to learn new equipment and processes, and quickly demonstrate proficiency in their operation.
• Read and interpret manufacturing procedures, engineering drawings, and inspection procedures and comply with their requirements.
• Demonstrates accuracy, thoroughness and monitors own work to ensure quality.
• Practice and always advocate good safety skills.

Education and Experience

• Experience in FDA/GMP/ISO environment preferred.
• 2+ years of experience in a medical device environment preferred.

Location & Position Details

• This position is based out of our office in Irvine, California 92618.
• Contract to Hire

Pay Rate

$19.00 per hour

Hours

• Swing Shift: Mon - Thurs, 3:30pm - 2:00am + 5% comp (trains on 1st shift for first couple of weeks)
• Weekend Shift: Fri - Sun, 5:00am - 5:00pm + 7% comp (trains on 1st shift for first couple of weeks)

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.