Failure Analysis Tech III job in Irvine

About Beta Bionics
Beta Bionics, Inc. is a medical technology company working to commercialize the world’s first bionic pancreas called the iLet®. The iLet bionic pancreas is a wearable investigational device designed to autonomously control glucose in people with diabetes or other conditions of glycemic dysregulation.
Fueled by investments from high-profile funds and strategic partners and leveraging technology backed by years of clinical data, we are now entering a tremendously exciting phase in our development as we prepare to begin our large pivotal clinical trial and anticipated commercialization of the iLet bionic pancreas.

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 and dedicated to bringing to market our truly disruptive technology. 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 us on this journey to achieve Beta Bionics’ bold commitment to the millions of people waiting for the iLet bionic pancreas!

Failure Analysis Technician III/IV
Performs electrical and mechanical failure analysis techniques on returned products in support of failure investigation. Provides review of product manufacturing data including production test results to evaluate lot to lot correlation of failures. Prepares failure investigation reports in support of Beta Bionics’ Complaint Process. Participates in process improvement activities as requested.

Location and Travel
Irving CA & 0-5% travel

Key Job Responsibilities

• Responsible for component level failure analysis on returned insulin pumps and disposable devices
• Responsible for evaluating product manufacturing history, including test results, 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 Beta Bionics’ 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
• Performs complicated tests requiring considerable judgment in determining work methods and interpreting test results with minimal supervision
• Perform other assignments as needed
Required Education and Experiences
• Associate’s Degree in Electronics or Computer Technology or combination of education and applicable work experience
• Strong knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs)
• Strong knowledge of electronic devices, systems, and components
• Ability to use basic hand tools such as drills, soldering irons, micrometers, calipers, 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 and the Internet
• Ability to work well with others in a cross-functional team environment

Qualifications
• 3+ years of experience in Medical Device, Instrumentation, or Consumer Electronics.
• Experience in Technical Service Operations
• Experience in high volume medical device components desirable
• Experience in FDA/GMP/ISO environment
• Experience in troubleshooting electromechanical assemblies
• Requires immunization against Hepatitis B & C
• Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus
• Specific hearing abilities required by this job include being able to hear alert tones from the product, test equipment, and other auditory cues during use
• Employee must occasionally lift and/or move up to 25 pounds

Benefits
• Training and mentorship with ongoing learning and development courses
• Comprehensive medical and dental coverage
• 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.