Failure Investigation Engineer I

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 a "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 t:slim X2 insulin pump with Control-IQ technology. We're also 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. Since many of our own team members live with type 1 diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more attandemdiabetes.com.

A DAY IN THE LIFE:

A team member contributing to the testing, troubleshooting, documentation, and testing of electronic components in the Company's medical devices. Provides technical and process leadership for the evaluation of returned products within an FDA-regulated environment. Provides technical leadership and product knowledge on the electrical and mechanical characteristics of systems and/or integrated circuits, components, sub-components, and systems to determine the cause of failure, including the verification of analog and digital performance. Reviews failure investigation reports and provides support to the Quality organization for preventative actions (CAPA) complaint investigation process. Develops methods, processes, procedures, and equipment that will improve the failure investigation process and/or reduce failures.

• 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.
• Review product manufacturing history, including test results, in support of identifying lot-to-lot correlations for the root cause.
• Investigates component-level failure analysis to determine performance and failure modes.
• Interprets electrical schematics in support of troubleshooting of electromechanical devices.
• Reviews failure analysis reports and recommends corrective actions to the Quality organization.
• Work closely with Development Engineering, Quality Engineering, Manufacturing Engineering, and Sustaining Engineering on product reliability evaluations.
• 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.
• Collaborates 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.
• Assist in the technical development of automated and manual assembly techniques, tooling, and identify electro/mechanical testing development to improve product manufacturability.
• Provide training to manufacturing personnel on procedure, process, and equipment changes.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
• Develop tests and test fixtures required to conduct Accelerated Life Testing and Failure Analysis.
• Provides engineering-level support to technicians and test operators on the team.
• Performs data analysis and reviews test results with the project team as needed.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

YOU'RE AWESOME AT:

• Knowledge of Good Documentation Practices (GDP).
• Exposure to testing methodology in a manufacturing environment is valuable.
• Able to work effectively in a team environment and convey information-related failure investigation with the cross-functional engineering teams in R&D and Operations.
• Failure investigation experience with electromechanical devices is highly desirable.

YOU'LL NEED:

• Bachelor's degree in electrical engineering or related field.
• Experience in the medical device field including test documentation, assembly, and testing of biomedical devices, including experience with test methods and test equipment.
• At least 1 year of hands-on device failure analysis experience
• Experience with Customer Technical Services is highly desirable.
• Experience in FDA/GMP/ISO environment.
• Lean Manufacturing experience desirable.

WHAT'S 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 https://www.tandemdiabetes.com/careers.

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 don't meet 100% of a job description's criteria - maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $70,000 to $88,000 annually. 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 bonus, equity, and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You'll also receive 10 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem's benefits here!

YOU SHOULD KNOW:

Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire.

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 Tandem's CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants.

APPLICATION DEADLINE:

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

#LI-Onsite #LI-BC1

SPONSORSHIP:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.