Jobs at Tandem Diabetes Care, Inc.

Sr. Software QA Engineer responsible for ensuring medical device software products meet regulatory requirements and quality standards throughout the development lifecycle.…See more Reviews design control deliverables, risk management documentation, verification and validation activities, and software anomalies for compliance with FDA, ISO, and company procedures. Participates in design reviews, traceability analysis, CAPA investigations, and process improvement initiatives while supporting audits and regulatory inspections.

Sr Software Test Engineer I leads test projects for an automated insulin delivery system, defining schedules, developing validation test plans, and overseeing test automation frameworks and CI systems. The role requires expertise in embedded or cloud-based programming (JavaScript, C, or C#), familiarity with IEC 62304 medical device standards, and the ability to identify software architecture impacts across the platform.…See more Responsibilities include managing cross-functional test reviews, conducting software audits, assisting with failure diagnosis and replication, and preparing detailed test reports for product evaluation. The position demands 7+ years of QA/test engineering experience, with proven expertise in test automation frameworks and scripting languages.

Sr. Software Test Engineer I develops and implements software validation test plans for embedded medical devices, with responsibility for test strategy, automation, and cross-functional coordination.…See more The role requires expertise in test automation frameworks, understanding of embedded software architecture, and knowledge of medical device standards (IEC 62304). The engineer will lead test plan reviews, diagnose product failures, manage test documentation, and work closely with R&D and quality teams to ensure compliance with specification requirements.

Lead compliance testing and certification activities for a portfolio of medical devices, developing test strategies, managing external laboratories and certification bodies, and ensuring products meet FDA, safety, EMC, wireless, and regulatory requirements. Partner with Engineering, Quality, and Regulatory Affairs to identify compliance risks early and drive mitigation strategies.…See more Manage a team of compliance engineers and test professionals, oversee departmental budgets, and continuously improve compliance testing processes and best practices.