Failure Investigation Technician II

Tandem Diabetes Care•San Diego, CA

1d•$23 - $27•Onsite

About The Position

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. 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 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. Mains 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.

Requirements

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.
High School Diploma or equivalent required.
Associate’s Degree in Electronics or Computer Technology or equivalent combination of education and applicable job 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 with troubleshooting electromechanical assemblies.

Nice To Haves

Solidworks experience desirable.
Experience in high volume medical device assembly of plastic components desirable.
Experience in FDA/GMP/ISO environment.
Experience in Technical Service Operations

Responsibilities

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.