Failure Investigation Tech II — Med Device QA & Root Cause

Tandem Diabetes Care Europe B.V.; California; On-site; USD 31,000 - 37,000; Full time

Benefits offered by this job

Health care benefits

11 paid holidays

20 days PTO

401k with match

Employee Stock Purchase plan

Job summary

Tandem Diabetes Care is seeking a Failure Investigation Technician II to evaluate returned products in an FDA-regulated environment. You will perform electrical and mechanical failure analysis to support investigations and CAPA reporting, reviewing manufacturing data to identify root causes and drive process improvements.

Responsibilities include verification testing, documentation of findings, and collaboration with Engineering and Quality teams to resolve issues while following cGMP

Qualifications

• 3 years experience in a multidisciplinary manufacturing engineering support environment in Instrumentation, Biomedical, or Consumer Electronics.
• Experience in FDA/GMP/ISO environment.
• Experience in high volume medical device assembly of plastic components desirable.
• Experience with troubleshooting electromechanical assemblies.

Responsibilities

• 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 to identify correlations for root cause.
• Tests and measures component level failure analysis to determine performance and failure modes.
• Interprets electrical schematics in support of troubleshooting electromechanical devices.
• Documents findings and provides failure analysis information for CAPA reports.
• Maintains and analyzes problem logs to report recurring issues to QA and product development.
• Works with Engineering and Quality staff to investigate failures and determine root cause.
• Performs tasks per written/verbal instructions in compliance with cGMP.
• Performs other assignments as assigned.

Skills

QSR/GMP knowledge

Electronics fundamentals

Mechanical drawings

Electrical schematics

Hand tools

MS Office

Solidworks

Team collaboration

Documentation

Education

Associate's Degree in Electronics/Computer Technology

High School Diploma or equivalent

Tools

Soldering iron

Micrometers

Calipers

Test equipment

Microsoft Office

Job description

Tandem Diabetes Care is seeking a Failure Investigation Technician II to evaluate returned products in an FDA-regulated environment. You will perform electrical and mechanical failure analysis to support investigations and CAPA reporting, reviewing manufacturing data to identify root causes and drive process improvements.

Responsibilities include verification testing, documentation of findings, and collaboration with Engineering and Quality teams to resolve issues while following cGMP