Senior Field Study Tester - Medical Device Systems

Tandem Diabetes Care Inc.; California; On-site; USD 44,000 - 55,000; Full time

Job summary

Tandem Diabetes Care is seeking a Sr. Field Study Test Associate I to support field studies across connected devices, mobile apps, and software-enabled workflows, ensuring study readiness and robust validation in real‑world use conditions.

You will work closely with Systems Test, Software Engineering, Product, Clinical, Quality, and Project Management teams to troubleshoot issues, document results, and help drive study success while maintaining HIPAA compliance at Tandem's San Diego, CA campus.

Qualifications

• High School diploma/GED, required.
• 3+ years of experience supporting clinical research, medical device testing, system testing, product validation, or related activities.
• 3+ years of experience in medical device testing, with understanding of experimental design and study protocol development.
• Associate's or Bachelor's degree in Life Sciences, Clinical Research, Engineering, Computer Science, or a related field preferred.

Responsibilities

• Performs software and systems testing to validate end-to-end product behavior across devices, mobile apps, and connected workflows in real-world use conditions.
• Conducts pre-study validation of systems, devices, materials, and workflows, including smoke testing, configuration verification, connectivity validation, and readiness assessments prior to participant use.
• Coordinates and executes software and systems-focused study activities throughout the study lifecycle, including setup, validation, execution, monitoring, data collection, and closeout.
• Collects and documents diagnostic information, system logs, and study observations to support issue investigation and resolution.
• Contributes to level-of-effort estimates and planning for new study requests.
• Collaborates with Systems Test, Software Engineering, Product, Clinical, Quality, and Project Management to troubleshoot issues and achieve study objectives.
• Assists in developing and executing study protocols evaluating functionality, usability, performance, and interoperability across hardware, software, mobile, and cloud interfaces.
• Supports validation of software releases, system updates, and integrated product workflows through structured field and usability testing.
• Maintains complete study documentation including plans, results, logs, records, and deviations.
• Identifies and escalates study-related issues and risks; partners with cross-functional teams for timely resolution.
• Prepares study status updates, reports, and presentations for stakeholders.
• Identifies opportunities for process improvements and refining study processes, tools, and best practices.
• Ensures compliance with Privacy/HIPAA and other regulatory requirements.
• Performs other duties as assigned.

Skills

Independent execution

Problem solving

Documentation

Cross-functional collaboration

Attention to detail

Education

Associate's or Bachelor's degree in Life Sciences, Clinical Research, Engineering, Computer Science, or related field

Job description

Tandem Diabetes Care is seeking a Sr. Field Study Test Associate I to support field studies across connected devices, mobile apps, and software-enabled workflows, ensuring study readiness and robust validation in real‑world use conditions.

You will work closely with Systems Test, Software Engineering, Product, Clinical, Quality, and Project Management teams to troubleshoot issues, document results, and help drive study success while maintaining HIPAA compliance at Tandem's San Diego, CA campus.