Lead Test Technician

$75,000 - $100,000/Yr

Beta Bionics - Irvine, CA

posted 12 days ago

Full-time - Senior
Irvine, CA
Miscellaneous Manufacturing

About the position

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.

Responsibilities

  • 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.

Requirements

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

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
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