Medical Device Failure Investigator I

Tandem Diabetes Care Europe B.V.; California; On-site; USD 28,000 - 32,000; Full time

Benefits offered by this job

Health benefits from day 1

11 paid holidays per year

20 days of PTO with accrual from day 1

401(k) with company match

Employee Stock Purchase Plan

Incentive compensation

Equity

Job summary

Tandem Diabetes Care Europe B.V. is seeking an entry-level Failure Investigation Technician to provide technical and process support in an FDA-regulated environment. You will assist Sr.

Technicians by evaluating returned products, understanding electrical and mechanical characteristics, and helping determine causes of failure. Onsite in San Diego, CA, with a Monday–Friday schedule from 7:00 AM to 4:00 PM PST.

Qualifications

• High School Diploma or equivalent required.
• Associate Degree in Electronics Technology, Engineering Technology, Mechanical Technology, or a related technical discipline preferred.
• 1 year of experience in a technical role, preferably in a medical device manufacturing environment.

Responsibilities

• Perform the failure investigations of returned insulin pumps and disposable devices; documents findings and provides data used for trending.
• Conduct verification testing of returned medical devices to approved protocols.
• Review product manufacturing history, including rest results, to identify lot-to-lot correlations for root cause.
• Investigate component level failure analysis to determine performance and failure modes.
• Interpret electrical schematics in support of troubleshooting of electromechanical devices.
• Review failure analysis reports, and recommend corrective actions to the Quality organization.
• Maintain investigation process and analyze problem logs/trends to identify issues to Failure Investigation Management.

Skills

Electrical theory basics

Technical communication

Teamwork / collaboration

MS Office

Electrical test equipment

Education

High School Diploma or equivalent

Associate Degree in Electronics/Engineering/Mechanical Technology

Tools

Microsoft Office

Job description

Tandem Diabetes Care Europe B.V. is seeking an entry-level Failure Investigation Technician to provide technical and process support in an FDA-regulated environment. You will assist Sr.

Technicians by evaluating returned products, understanding electrical and mechanical characteristics, and helping determine causes of failure. Onsite in San Diego, CA, with a Monday–Friday schedule from 7:00 AM to 4:00 PM PST.