Sr. Software Quality Assurance 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.

A DAY IN THE LIFE:

The Sr. Software Quality Assurance Engineer I is responsible for providing leadership on quality standards and risk management activities across core teams. They guide our teams on best quality practices using their strong understanding of software lifecycle development, quality processes, and risk management activities from software development to launch. This role will also drive optimization and continuous improvement of processes to meet department, business unit and company objectives.

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.
• Ensures that software development and risk management activities conform to Tandem’s quality processes.
• 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.
• Evaluates and recommends tools, technologies, and processes.
• Embraces the Design Control process by participating in design reviews and maintaining design history files.
• Confirms completion of required training plan before assuming job responsibilities.
• Supports other departments as needed and considers project-wide impacts in decision making.
• Provides quality input to Complaint, FI, CA and CAPA investigations and executes corrective actions when applicable.
• 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, IEC 62304.
• Familiar with Good Documentation Practices (GDP).
• Ability to effectively use MS Office suite (Word, Excel, Outlook) and other applicable software packages.
• Experience with JavaScript, C, Jasmine or other software language preferred.
• Excellent written and verbal communication skills.
• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• 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.
• Knowledgeable of software life cycle models other than “waterfall”.
• 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.
• Experienced with Good Design Practices.
• 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.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $105,000 - 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.

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: