Job Details

Beta Bionics Assembler III

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 include:

• 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 include:

• 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 include:

• 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 and 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.