Sr Field Study Test Engineer I (Systems Reliability Tester)

Tandem Diabetes Care•Ruth, CA

2d•$120,000 - $150,000•Hybrid

About The Position

The Senior Field Study Test Engineer I is a highly technical and systems-oriented engineer that leads non-clinical field studies for in-development products from planning through definition, execution, analysis, and final documentation. This role is responsible for translating study requests into well-defined study plans and protocols, ensuring the integrated system under study is technically ready, defining meaningful KPIs in partnership with data analytics and cross-functional teams, and turning field observations into actionable insights for product & development teams. This individual will help ensure field studies are representative of real-world use, technically rigorous, and aligned to product and systems learning objectives.

Requirements

Strong understanding of integrated system behavior in complex product ecosystems.
Ability to discuss technical scope across multiple domains, including hardware, embedded software, mobile applications, connectivity, cloud, and end-to-end workflows.
Strong analytical mindset with the ability to interpret both qualitative observations and quantitative KPI trends.
Ability to identify system-level failure modes and translate field findings into clear, actionable issues for development teams.
Excellent written communication and documentation skills.
Strong proficiency with Microsoft Word, Excel, and PowerPoint.
Strong cross-functional collaboration and stakeholder management skills.
Familiarity with participant-facing workflows, training materials, and study support processes.
Comfortable operating in a regulated product development environment with defined documentation and quality expectations.

Nice To Haves

Bachelor's degree in engineering, Systems Engineering, Biomedical Engineering, Computer Engineering, or related technical field, or equivalent combination of education and job experience.
5+ years of relevant experience in systems engineering and integration testing.
Experience working on multi-component connected products or cyber-physical systems.
Experience creating structured plans, protocols, test/study scenarios, and readiness criteria for product evaluations.
Product validation, field reliability, or technical study leadership.
Medical devices or other regulated industries.
Non-clinical human subject research studies, usability investigations, or simulated use evaluations.
Defining KPIs and working with analytics/data teams on data ingestion and readouts.
Issue tracking systems, defect triage, and cross-functional debugging.

Responsibilities

Owns and leads end-to-end (E2E) software studies, providing strategic direction across planning, kickoff, execution, and final readouts while ensuring alignment to program and business objectives.
Defines, documents, and continuously refines study plans, protocols, and key performance indicators (KPIs) using scoping documents and expert-level understanding of the E2E system architecture and workflows.
Participates effectively in technical scoping and readiness discussions by understanding end-to-end system behavior across hardware, embedded, mobile, cloud, and supporting tools.
Serves as a senior cross-functional partner to Clinical, Regulatory, and Engineering teams, driving documentation for Institutional Review Board (IRB) submission for on-body studies.
Translates complex business needs and technical requirements into well-scoped, executable study deliverables, balancing speed, quality, and risk.
Proactively monitors study health by analyzing trends, KPIs, and issues, assesses impact and risk, and leads timely escalation and resolution with senior stakeholders.
Authors and reviews high-quality study deliverables including executive-level reports, summaries, and documentation that synthesize outcomes, insights, and actionable recommendations.
Collaborates with Data Analytics / Data Science and cross-functional teams to define KPIs, data collection requirements, and readout expectations for each study.
Defines and coordinates pre-study smoke / sanity testing for the system under test, including software builds, test environment, and study materials for execution.
Anticipates realistic user workflows, usage patterns, edge cases, in-field challenges, etc., and incorporates them into representative study tasks and scenarios.
Analyzes reported issues for system-level patterns and escalates defects, risks, and critical observations to development teams and stakeholders in a timely manner.
Contributes to continuous improvement of field study templates, protocols, workflows, and standard methods for scalable study execution.