Failure Investigation Technician II

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

GROW WITH US:

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to "innovate every day," put "people first," and take the "no-shortcuts" approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

Evaluates returned product in an FDA regulated environment. Performs electrical and mechanical failure analysis techniques in support of failure investigation. Provides review of product manufacturing data including production test results to evaluate lot to lot correlation of failures. Prepares failure investigation reports in support of Tandem's Complaint Process. Participates in process improvement activities as requested to improve the failure analysis process and/or reduce failures.

Failure Investigation Technician II's are also responsible for:

• 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, in support of identifying lot to lot 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 identify and report recurring issues to quality assurance management and product development.
• Works with Engineering and Quality staff as needed to investigate failures and determine root cause.
• Performs technical tasks per written and verbal instructions in compliance with company and cGMP requirements including accurate documentation.
• Performs other assignments as assigned.

WHAT YOU'LL NEED:

Knowledge, skills & abilities:

• Strong knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs).
• Strong knowledge of electronic devices, systems and components.
• Ability to use basic hand tools such as drills, soldering irons, micrometers, calipers, etc.
• Ability to operate electrical and mechanical equipment and interpret results.
• Must be able to read and interpret mechanical drawings and electrical schematics.
• Able to effectively share information related to work product in verbal and written form.
• Able to contribute to the team by supporting the acceptance of new team members.
• Demonstrated ability to work accurately, to follow instructions and schedules, and handle multiple priorities.
• Has knowledge of personal protective equipment (PPE) for protecting against blood-borne and other bio-hazardous pathogens.
• Competent with Microsoft Office and the Internet.
• Solidworks experience desirable.

Minimum Education:

• High School Diploma or equivalent required.
• Associate's Degree in Electronics or Computer Technology or equivalent combination of education and applicable job experience.

Minimum experience:

• 3 years experience in a multidisciplinary manufacturing engineering support environment in one of the following industries: Instrumentation, Biomedical, or Consumer Electronics to include
• Experience in high volume medical device assembly of plastic components desirable.
• Experience in FDA/GMP/ISO environment.
• Experience in Technical Service Operations
• Experience with troubleshooting electromechanical assemblies.

COMPENSATION & BENEFITS:

The base hourly pay for this position is $22.50 - $27.00 . Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes incentive compensation, equity, and a robust benefits package

• Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts.
• You'll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.

YOU SHOULD KNOW:

Qualified applicants with arrest or co