Failure Analysis Technician II - Medical Devices

Tandem Diabetes Care, Inc.; North Dakota; On-site; USD 64,472,000 - 77,366,000; Full time

Benefits offered by this job

Health benefits from day 1

11 paid holidays per year

Minimum 20 days paid time off (accrual

401k with company 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 and perform failure analysis. You will review production data and prepare investigation reports to support CAPA activities.

Work with Engineering and Quality teams to identify root causes, document findings, and ensure compliant corrective actions in a fast-paced medical device setting. Benefits and a competitive pay range accompany this role.

Qualifications

• Knowledge of QSRs/GMPs and related regulatory expectations.
• Proficiency with electronic devices, systems and components.
• Ability to read and interpret mechanical drawings and electrical schematics.
• Experience with hand tools, measurement devices, and basic lab equipment.
• Familiarity with FDA/GMP/ISO environments and CAPA processes.

Responsibilities

• Evaluate returned products in an FDA-regulated environment.
• Perform failure analysis to support root-cause investigation.
• Review manufacturing data and production tests for lot-to-lot correlations.
• Prepare failure investigation reports for CAPA and quality records.
• Collaborate with Engineering and Quality to resolve issues and improve processes.

Skills

Quality System Regulations (QSRs/GMPs)

Electronic devices, systems & parts

Reading mechanical drawings & schem..

Soldering & hand tools

Micrometers & calipers

Microsoft Office

Team collaboration

FDA/GMP/ISO environment experience

Education

High School Diploma or equivalent

Associate’s Degree in Electronics or Computer Technology

Tools

Solidworks

Microsoft Office

Job description

Tandem Diabetes Care is seeking a Failure Investigation Technician II to evaluate returned products in an FDA-regulated environment and perform failure analysis. You will review production data and prepare investigation reports to support CAPA activities.

Work with Engineering and Quality teams to identify root causes, document findings, and ensure compliant corrective actions in a fast-paced medical device setting. Benefits and a competitive pay range accompany this role.