Operations Lead - Swing Shift (2nd Shift)

Operations Lead

The Operations Lead will oversee and coordinate work associated with production assembly and packaging. He or she will also support inventory management, shipping, and receiving on an as needed basis. The critical attributes and skills required for this position include determination and communication of priorities, assembly skills, hands-on problem solving skills, ability to meet schedules, attention to detail including quality requirements, takes initiative, and has the ability to work well within a team work environment. The lead will also be responsible for providing routine reporting on production and inventory status.

Essential Duties and Responsibilities

• Oversee and coordinate the work of Assemblers ensuring that all work meets compliance to design and inspection specifications, identify when assemblies or components are nonconforming, and take action to prevent further non-conforming assemblies or components.
• Train assemblers to build product with a level of quality, consistency and speed to meet the design and manufacturing specifications and production schedules.
• Comply with company Standard Operating Procedures (SOPs) and departmental policies and procedures, objectives, the quality assurance program, as well as safety and environmental standards.
• Demonstrate Good Manufacturing Practice (GMP) in compliance with Quality System requirements.
• Ability to evaluate production equipment and tooling to ensure compliance with specifications and procedures.
• Ability to learn new equipment operation and assembly 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 in English only.
• Follow the production schedule or assignments, and demonstrate autonomy in maintaining these priorities, but seek guidance when there is confusion or uncertainty, conflicts, or competing priorities.
• Perform training and monitoring of other production workers as needed or as directed by the supervisor.
• Hires, trains, motivates and develops Operations staff.
• Ensures appropriate communication processes are established within and across functional groups. Communicates information related to quality management system effectiveness.
• Works in accordance with quality system procedures.
• Support other assignments outside of standard production such as performing inventory counts, research and development projects, validation execution, manufacturing engineering or facility requirements, or other as needed.

Required Education and Experience

• High School Diploma required.
• 5+ years related industry experience, preferably in medical device production assembly.
• Working knowledge of operations.
• Strong manual dexterity for production assembly, preferably with adhesive bonding experience.
• Strong hands-on problem solving skills with the ability to create improvements or new approaches that can be turned into realistic plans and real results.
• 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. All documents are in English only.
• Learn and comply with EN ISO 13485, Medical Device Quality System Requirements standard.
• Comply with regulatory and internal policies.
• Support company goals and objectives, policies and procedures, and FDA regulations; deliver on commitments and meet deadlines.
• Ability to work on a computer with various programs to transact product within the production system or to generate memos, spreadsheets or documentation as needed.
• Work well within a team by establishing and maintaining productive relationships with fellow employees and customers.
• Ability to communicate clearly both verbally and in writing and ability to demonstrate active listening.

Preferred Experience and Qualifications

• Familiarity with medical device industry regulatory requirements and others that may be applicable to operations.
• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor(s).
• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
• Excellent communications skills, including ability to represent the company in both internal and external audiences.
• Strong team building/leadership skills.
• Must be highly organized and able to execute tactics in a timely manner.

Work Environment and Personal Protective Equipment

• Works in a Lab, Clean Room, and Office environment, within a well-lighted work area with good ventilation and normal noise levels from lab, shop equipment, and clean room.

Physical Demands

• Sitting or standing at a production work station with frequent walking to transact product; intermittently write or use a keyboard to communicate through written means.
• Some lifting up to 20 lbs. may be required.
• This position requires travel up to 5% depending upon business needs.

Location

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

Pay Range

$30 - $34 per hour (+5% shift differential)

Hours

• Swing Shift: Mon - Thurs, 3:30pm - 2:00am + 5% comp

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

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.