Assembler III

Beta Bionics, Inc.; Irvine (CA); On-site; USD 10,000 - 60,000; Full time

Job summary

Beta Bionics, Inc. seeks an Assembler III to join their team in Irvine, California. This role involves electro-mechanical device assembly and ensures compliance with FDA and quality standards. Candidates should have 4-5 years of experience in medical device production, with a focus on attention to detail and teamwork.

Qualifications

• High School Diploma preferred.
• 4-5 years related industry experience in medical device production assembly preferred.
• Experience in FDA/GMP/ISO environment preferred.

Responsibilities

• Perform duties associated with electro-mechanical assembly and packaging.
• Comply with FDA regulations and Good Manufacturing Practices.
• Assist with training new assemblers.

Skills

Attention to detail

Manual hand assembly

Interpersonal skills

Communication

Quality assurance

Education

High School Diploma

Tools

Basic hand tools

Micrometers

Calipers

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.

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!

*Contract to Hire

Summary/Objective:

The Assembler III 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.
• Ability to work with minimal supervision.
• 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 advocate good safety skills at all times.
• Assist with training new assemblers to meet quality and performance standards.

Required Education, Experience, and Skills

• High School Diploma preferred.
• Preferred 4-5 years related industry experience in medical device production assembly.
• 4-5 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.
  
• Ability to teach and train new assemblers.

Location & Position Details

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

Pay Rate

$25.00+ 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)

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.