Sr. Software Quality Assurance Engineer I

San Diego, CA, United States

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:

At Tandem, the Sr. Software Quality Assurance Engineer I is a core team leader who ensures that our software projects are meeting stringent regulations and quality standards. They are the go-to experts for regulatory compliance and champion for process excellence by driving our teams towards conformance at every stage of development.

Please note that this role will not be responsible for any software development or testing.

Serves as a Quality representative on project core teams. Provides quality guidance throughout software development and maintains all quality-related deliverables.

Ensures quality integration into the overall functions of software development, scientific computation, and data acquisition.

Review/Approve various software lifecycle project deliverables based on procedural requirements.

Performs risk analysis and is responsible for risk management activities. Identifies, evaluates, and documents product risks. Coordinates risk-related updates with risk management team.

Provides traceability analysis and reports to ensure project requirements have been met

Participates on the Software Review Board (SRB) and Extended Software Review Board (ESRB) to evaluate and disposition software issues and Unresolved Anomalies.

Analyzes test results to ensure existing functionality and requirements are met, and if necessary, recommends corrective action.

Embraces the Design Control process by participating in design reviews and maintaining design history files.

Provides quality support and guidance for audits.

YOU’RE AWESOME AT: Knowledge of mobile, embedded software, or web-based technologies preferred

Has working knowledge of FDA and international regulations, e.g. QSRs, ISO 14971, ISO 13485, IEC 62304.

Familiar with Good Documentation Practices (GDP).

Excellent written and verbal communication skills

Skilled at promoting team cooperation and a commitment to team success.

Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.

WHAT YOU'LL NEED: Requires a bachelor's degree in Engineering or Computer Sciences or related field or equivalent combination of education and years of applicable experience.

5 plus years’ experience in the field of software Quality Assurance for medical devices or an FDA-regulated industry, including experience with conceptual design to market release.

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 $95,800 - 131,000 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 (accrual 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!

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-Hybrid #LI-KS1 #LI-Remote