Assembler I - III (All Shifts)

Beta Bionics Inc; Irvine (CA); On-site; USD 26,000 - 34,000; Full time

Job summary

Beta Bionics Inc in Irvine, California is seeking an Assembly Technician to perform electro-mechanical and clean room device assembly and packaging. The role emphasizes manual dexterity, attention to detail, teamwork, and producing high-quality results.

The position requires a high school diploma and 2–5 years of medical device assembly experience, familiarity with GMP/ISO environments, and the ability to read engineering drawings.

Qualifications

• High School Diploma required; 2–5 years medical device assembly preferred.
• Experience in FDA/GMP/ISO environments preferred.
• Ability to read engineering drawings and procedures.
• Attention to detail and quality control.
• Ability to operate hand tools and basic metrology instruments.

Responsibilities

• Perform electro-mechanical and clean room device assembly and packaging.
• Follow SOPs/DOPs and ISO standards; maintain professional relationships with staff, clients and suppliers.
• Read and interpret manufacturing drawings and procedures; ensure compliance.
• Demonstrate accuracy, thoroughness and monitor own work for quality.
• Practice and advocate good safety skills.

Skills

QSRs/GMPs

Hand tools

Reading drawings

Team collaboration

Attention to detail

Education

High School Diploma

Tools

Micrometers

Calipers

Electrical equipment

Mechanical equipment

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.

*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.

*Contract to Hire

Summary/Objective:

The Assembler 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

[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]

• 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. All documents are written in English.
• Demonstrates accuracy, thoroughness and monitors own work to ensure quality.
• Practice and always advocate good safety skills.

Required Education, Experience, and Skills

• High School Diploma preferred.
• Preferred 2-5 years related industry experience in medical device production assembly.
• 2-5 years of experience in a medical device environment preferred.
• Experience in FDA/GMP/ISO environment preferred

Required Skills

• Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs).
• Ability to use basic hand tools such as hand tools, micrometers, calipers, etc.
• Ability to operate electrical and mechanical equipment and interpret results.
• Ability to work well with others in a cross-functional team environment.
• Attention to detail to ensure high quality work and to detect when there are issues with tooling,
  materials, processes and quality.
• Read, interpret, and learn engineering drawings, manufacturing procedures and processes
  and inspection procedures.
• Ability to work on a computer with various programs to transact product within the production
  system and complete online training.
• Ability to communicate clearly both verbally and in writing and ability to demonstrate active
  listening.

Location & Position Details

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

Pay Rate

$19-$25+ per hour

Hours

• Day Shift (1st Shift): Mon - Thurs, 5:00am - 3:30pm
• Swing Shift (2nd Shift): Mon - Thurs, 3:30pm - 2:00am + 5% comp
• Weekend Day Shift (3rd Shift): Fri - Sun, 5:00am - 5:30pm + 7% comp
• Weekend Swing Shift (4th Shift): Fri - Sun, 5:00pm - 5:30am + 7% comp
• This position may require occasional overtime, schedule adjustments, or additional weekday or weekend coverage based on business needs, production demands, training, or operational requirements.

Work Environment

• 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.
• Sitting or standing at a production workstation with frequent walking to transact product; intermittently write or use a keyboard to communicate through written means.

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.

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.