Lead Test Technician

Beta Bionics, Inc.; Irvine (CA); On-site; USD 75,000 - 100,000; Full time

Job summary

Beta Bionics, Inc. is looking for a skilled Lead Test Technician in Irvine, CA. This role focuses on testing, troubleshooting, and ensuring the regulatory compliance of insulin pumps. Candidates should have extensive experience in medical device testing and a strong understanding of industry regulations. The company offers a collaborative environment with opportunities to impact diabetes management solutions.

Benefits

Comprehensive medical and dental coverage

FSA and HSA Plan Options

401(k) program with employer match

Generous vacation accrual and paid holiday schedule

Qualifications

• 7+ years of experience in medical device testing, especially in insulin pumps.
• Proven expertise in troubleshooting electronic and mechanical systems.
• In-depth understanding of FDA regulations and quality standards.

Responsibilities

• Conduct advanced testing on insulin pumps, ensuring compliance with safety standards.
• Design and modify test procedures for new products.
• Document test findings and collaborate with design engineers.

Skills

Troubleshooting

Attention to Detail

Written Communication

Verbal Communication

Data Analysis

Education

Associate’s Degree in Electronics, Engineering Technology, Biomedical Engineering, or related field

Tools

Diagnostic Equipment

Multimeters

Oscilloscopes

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.

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.

Location - Irvine, CA. This is an on-site/in-person role.

Summary/Objective

We are seeking a skilled and highly experienced Lead Test Technician to join our team at Beta Bionics, a leading innovator in the development of medical devices, particularly insulin pumps for diabetes management. The Lead Test Technician will be responsible for conducting complex testing, troubleshooting, and calibration activities to ensure the functionality, quality, and regulatory compliance of our insulin pump devices. This position requires a strong understanding of medical device testing, electronics, and the regulatory environment for medical products.

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]

• Conducting Advanced Testing: Perform testing on insulin pumps and related components, ensuring they meet established performance, safety, and regulatory standards. This includes environmental, electrical, and functional tests.
• Test Development and Execution: Design, modify, and execute test procedures for new and existing products, ensuring that tests are comprehensive and aligned with product specifications and customer requirements.
• Data Collection and Analysis: Record and analyze test data, identify trends, and generate reports to support product quality improvement. Ensure all results are documented accurately in compliance with company and regulatory standards.
• Troubleshooting and Failure Analysis: Identify and troubleshoot issues in hardware and software using sophisticated diagnostic equipment. Analyze failure modes and work with cross-functional teams to resolve issues.
• Regulatory Compliance: Ensure all testing activities comply with industry regulations, including FDA, ISO, and IEC standards. Contribute to audits and inspections as required, ensuring that all documentation and testing is in line with these requirements.
• Collaboration: Work closely with design engineers, quality assurance, and manufacturing teams to ensure the successful testing and validation of devices. Provide technical support and recommendations based on test results.
• Process Improvement: Continuously assess and recommend improvements to testing methodologies, procedures, and equipment to enhance efficiency and accuracy in the testing process.
• Equipment Calibration and Maintenance: Perform routine calibration, maintenance, and troubleshooting of test equipment to ensure it remains in optimal working condition.
• Documentation: Ensure thorough documentation of testing processes, findings, and reports. Maintain accurate records in compliance with ISO 13485, 21 CFR Part 820, and other relevant regulations.

Required Education and Experience

• Associate’s degree in Electronics, Engineering Technology, Biomedical Engineering, Mechanical Engineering, or related field; or equivalent combination of education and experience.

Preferred Experience and Qualifications

Experience:

• 7+ years of experience in medical device testing, specifically in the insulin pump, diabetes care, or healthcare technology sector.
• Proven expertise in troubleshooting electronic and mechanical systems.
• In-depth understanding of medical device industry regulations (FDA, ISO 13485, 21 CFR Part 820).

Skills:

• Advanced proficiency in using diagnostic and test equipment (e.g., oscilloscopes, multimeters, environmental chambers, etc.).
• Strong understanding of electrical circuits, microelectronics, and embedded systems.
• Ability to read and interpret technical drawings, schematics, and specifications.
• Solid troubleshooting skills, with the ability to analyze complex systems and identify root causes of issues.
• Excellent written and verbal communication skills for clear documentation and team collaboration.
• Strong attention to detail and commitment to quality.
• Proficient in test automation and data analysis tools.

Work Environment and Personal Protective Equipment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopier, and scanners.

Physical Demands

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers.
• In office work is required.
• This position requires travel depending upon business needs.

Location

Irvine, CA. This is an on-site/in-person role.

Salary Range

$75,000 - $100,000

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.