Onsite Failure Analysis Technician I

Tandem Diabetes Care, Inc.; San Diego (CA); On-site; USD 28,000 - 32,000; Full time

Job summary

Tandem Diabetes Care is seeking an Entry-level Failure Investigation Technician to support the evaluation of returned products in a FDA-regulated setting. You’ll help determine failure causes by examining electrical/mechanical aspects of devices and reviewing manufacturing histories.

The role requires basic knowledge of electrical/mechanical theory, ability to read schematics, and comfort with data documentation. Fully onsite in San Diego, Monday–Friday, 7:00 AM–4:00 PM PST.

Qualifications

• High School Diploma or equivalent required.
• Associate degree in Electronics Technology, Engineering Technology, Mechanical Technology preferred.
• Equivalent combination of education, training, and relevant work experience will be considered.

Responsibilities

• Perform failure investigations of returned insulin pumps and disposable devices; document findings and provide data for trending.
• Conduct verification testing of returned medical devices to approved protocols.
• Review manufacturing history to identify lot-to-lot correlations for root cause.
• Investigate component-level failure analysis to determine performance and failure modes.
• Interpret electrical schematics to troubleshoot electromechanical devices.
• Review failure analysis reports and recommend corrective actions to Quality.
• Maintain investigation process and analyze problem logs to identify issues.
• Complete required training before assuming responsibilities.
• Ensure compliance with Privacy/HIPAA and regulatory requirements.

Skills

Electrical theory

Mechanical theory

Technical writing

Team collaboration

Microsoft Office

Electrical test equipment

Schematic interpretation

PPE knowledge

Education

High School Diploma

Associate degree in Electronics/Engineering/Mechanical Technology

Equivalent combination of education and experience

Tools

Multimeter/Oscilloscope

Job description

Tandem Diabetes Care is seeking an Entry-level Failure Investigation Technician to support the evaluation of returned products in a FDA-regulated setting. You’ll help determine failure causes by examining electrical/mechanical aspects of devices and reviewing manufacturing histories.

The role requires basic knowledge of electrical/mechanical theory, ability to read schematics, and comfort with data documentation. Fully onsite in San Diego, Monday–Friday, 7:00 AM–4:00 PM PST.