Failure Analysis Technician II — Medical Devices

Tandem Diabetes Care, Inc.; San Diego (CA); In loco; USD 31.000 - 37.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health care benefits

11 paid holidays per year

Paid time off (20+ days)

401k with company match

Employee Stock Purchase Plan

Descrizione del lavoro

Tandem Diabetes Care is seeking a Failure Investigation Technician II in San Diego to evaluate returned devices in an FDA-regulated environment and support failure investigations.

You will perform verification testing, review production data, and contribute to root-cause analysis to reduce failures. The role requires hands-on electrical and mechanical troubleshooting, documentation, and collaboration with Engineering and Quality teams.

Competenze

• High School Diploma or equivalent required.
• Associate’s Degree in Electronics or Computer Technology or equivalent combination.
• 3 years experience in multidisciplinary manufacturing engineering support.
• Experience in FDA/GMP/ISO environment.
• Experience with troubleshooting electromechanical assemblies.

Mansioni

• Participates in complaint investigations and failure analysis of returned insulin pumps and disposable devices.
• Conducts verification testing of returned medical devices to approved protocols.
• Evaluates product manufacturing history, including test results, to identify root cause correlations.
• Tests and measures component level failure analysis to determine performance and failure modes.
• Documents findings and provides failure analysis information for CAPA reports.
• Maintains and analyzes problem logs to identify recurring issues for QA and product development.

Conoscenze

QSR/GMP knowledge

Electronics

Soldering & hand tools

Read schematics

Documentation

CAPA support

Microsoft Office

SolidWorks

Formazione

Associate degree in Electronics

High School Diploma

Strumenti

Micrometers

Calipers

Soldering irons

Drills

Descrizione del lavoro

Tandem Diabetes Care is seeking a Failure Investigation Technician II in San Diego to evaluate returned devices in an FDA-regulated environment and support failure investigations.

You will perform verification testing, review production data, and contribute to root-cause analysis to reduce failures. The role requires hands-on electrical and mechanical troubleshooting, documentation, and collaboration with Engineering and Quality teams.