Software Quality And Design Controls Engineer Ii

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:
The Software Quality and Design ControlsEngineer II is responsible for providing quality guidance and support for software product launch, sustaining engineering software projects, and quality system activities to assure conformance to established specifications.
Please note that this role will not be responsible for any software development or testing, but rather guiding our software teams in quality assurance, risk management, and compliance activities to ensure the successful launch and sustainability of software products, while optimizing internal operations for efficiency and quality.

• • Provides quality support for software project teams throughout the software lifecycle, from design through launch.
  • Ensures quality integration into the overall functions of software development, scientific computation, and data acquisition.
  • Creates and reviews various software lifecycle project deliverables based on procedural requirements.
  • Performs risk analysis and is responsible for risk management activities: determines, evaluates and documents software risks from product design to post-launch.
  • Analyzes test results to ensure existing functionality and requirements are met, and if necessary, recommends corrective action.
  • Provides traceability analysis and traceability reports to ensure project requirements have been met
  • Participates on the Software Review Board (SRB) to evaluate and disposition software anomalies.
  • Reviews and approves CO's as well as provides quality input to support closure (QMS updates, Procedural changes, etc.)
  • Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable.

YOU'RE AWESOME AT:

• • Knowledge of mobile app technologies preferred.
  • Working knowledge of federal and other regulations including QSRs, ISO 14971, IEC 62304.
  • Skilled at promoting team cooperation and a commitment to team success.

WHAT YOU'LL NEED:

• • Requires a bachelor's degree in Engineering, Computer Sciences or related field or equivalent combination of education and years of applicable experience.
  • 2 plus years' experience working as a Software Quality Assurance Engineer in an FDA-regulated industry.
• 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.

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 $83,000 - 104,000 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 11 paid holidays per year, a minimum of 20 days of paid time off (accural starts on day 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.
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.
REFERRALS:
We love a good referral! If you know someone that would be a great fit for this position, please share!
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