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Failure Analysis Technician Location: US-CA-San Diego Jobcode: 2226716 Email this job to a friend
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GROW WITH US:
In Tandem means together, and we strive to embody that in every aspect of our business. Whether youre office-based or fully remote, Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and the healthcare providers supporting them through a positively different experience.
INNOVATE EVERYDAY
At Tandem, we strive to put our values into action. Our Team Up, No shortcuts approach has propelled us to be an industry leader and make significant strides in the diabetes technology space. We are proud to be the makers of the only color, touch-screen insulin pump that is capable of remote feature updates and compatibility with continuous glucose monitoring. Watch our latest video to see our product features and capabilities here:t:slim X2 Insulin Pump with Control-IQ Technology
A DAY IN THE LIFE:
The Failure Analysis Technician manages the failure investigations of returned products (insulin pumps and disposable devices), documents findings, and analyzes data to identify recurring issues. This role is also determines cause of failure and verifies analog/digital performance by exploring theelectrical and mechanical characteristics of the systems and/or integrated circuits, components, and sub-components.
Manages the failure investigations of returned insulin pumps and disposable devices; documents findings and provides data used for trending.
Oversees verification testing of returned medical devices to approved protocols.
Reviews product manufacturing history, including rest results, in support of identifying lot to lot correlations for root cause.
Investigates component level failure analysis to determine performance and failure modes.
Interprets of electrical schematics in support of troubleshooting of electromechanical devices.
Reviews failure analysis reports, and recommends corrective actions to the Quality organization.
Maintains investigation process and analyzes problem logs/trends to identify and report recurring issues to Quality Assurance and Product Development management.
Oversees technical tests and analyses of the Failure Investigation technicians.
Oversees Collaboration with other internal groups to respond to product inquiries and issues.
Confirms completion of required training plan before assuming job responsibilities.
Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
YOURE AWESOME AT:
Strong knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs).
Ability to efficiently collect and analyze data.
Ability to express technically complicated ideas and explain them to others.
Solidworks experience desirable.
Familiar with personal protective equipment (PPE) for protecting against blood borne and other bio-hazardous pathogens.
WHAT YOU'LL NEED:
Associates degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.
4 years experience in a technical role preferably in a medical device manufacturing environment.
Experience in product development, test, and validation
Experience in FDA/GMP/ISO environment.
Lean Manufacturing experience desirable.
WHATS IN IT FOR YOU?
In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit (link removed)
BE YOU, WITH US!
Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table. But sometimes we forget that when we dont meet 100% of a job descriptions criteria maybe youre feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.
REFERRALS:
We love a good referral! If you know someone that would be a great fit for this position, please share!
If you are applying for this job and live in California, please read Tandems CCPA Notice:
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#LI-Onsite
Tandem Diabetes Care
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