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!

*User must be carb aware.

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Summary/Objective:

Performs electrical and mechanical failure analysis techniques on returned products in support of failure investigation according to written procedures. Provides a review of product manufacturing data including production test results and device logs to evaluate lot to lot correlation of failures. Prepares failure investigation reports in support of Complaints Management and Sustaining Engineering projects. Participates in process improvement activities as requested.

** *Note:** This job description outlines the primary responsibilities and qualifications for a Failure Investigations Technician III, and it is intended to provide a comprehensive overview and is not exhaustive. Other duties may be assigned as necessary to meet the evolving needs of the organization.

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]

• Required Skills :
  • Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs).
  • Ability to use basic hand tools such as drills, drivers, micrometers, calipers, etc.
  • Ability to operate electronic measurement equipment such as DMMs, Oscilloscopes, Source Meters, Power Supplies etc.
  • Ability to operate electrical and mechanical equipment and interpret results.
  • Must be able to read and interpret mechanical drawings and electrical schematics.
  • Proficient with Microsoft Office (with emphasis in Excel) and online applications.
  • Ability to work well with others in a cross-functional team environment.
• Primary Duties & Responsibilities: * Responsible for component level failure analysis on returned insulin pumps and disposable devices. * Responsible for evaluating product manufacturing history, including test results and device logs, in support of identifying lot to lot correlations for root cause. * Responsible for interpreting electrical schematics in support of troubleshooting electromechanical devices. * Works with engineering staff as needed to investigate failures and determine root cause. * Excellent writing skills for creating failure analysis reports in support of complaint processes. * Complies with company and department requirements by documenting all work performed utilizing good organizational skills. * Accurately performs technical tasks per written and verbal instructions. * Perform other assignments as needed. * Support company goals and objectives, policies and procedures, and FDA regulations including compliance to EN ISO 13485, Medical Device Quality Standards. * Ability to work with minimal supervision. * Excellent interpersonal, verbal and written communication skills. Meticulous attention to detail and meeting deadlines. * Operates with high standards that are aligned to Certified B-Corp values. * Consider the beneficiaries of Beta Bionics' Public Benefit Mission with all actions and decisions.

Required Education and Experience

• Associate degree in a technical field; or equivalent education & experience.
• Knowledge of operations, production, quality, and customer service within the medical device industry preferred.

Work Environment and Personal Protective Equipment

• This job operates in a lab and warehouse environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners.
• Personal Protective Equipment may be required for laboratory or field work.

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; 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.
• May require shift work.
• Requires immunization against Hepatitis B & C.
• This position is based out of our office in Irvine, California.

Salary Range

$28 - $32 per hour

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.