Software QA Engineer

Software QA Engineer 2

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Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: to forever change how diabetes is managed and to unlock information and insights that drive better health outcomes. Fifty years later, we have pioneered an industry and are broadening our vision beyond diabetes to empower people to take control of health through personalized, actionable insights aimed at solving important health challenges.

We are driven by thousands of ambitious, passionate people worldwide who strive to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We have already changed millions of lives and aim to become a leading consumer health technology company while continually developing solutions for serious health conditions.

This functional department provides technical support and guidance to the software teams to ensure conformance to software development processes and applicable safety and quality system regulations and standards such as IEC 62304, ISO 13485, ISO 14971, and 21 CFR 820. We are responsible for various aspects of software design assurance with a focus on product improvement, new product development, and defect prevention.

We interface with different cross‑functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project Management, System Engineering, Clinical and others) and foster a positive team culture in a fast‑paced environment.

• This is not a test role

• You will actively participate as a core team member of the R&D Quality Assurance Engineering team.
• You will provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and other relevant regulations worldwide to the cross‑functional teams.
• You will lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams.
• You will provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA.
• You will provide guidance to Software Design and Test Teams for system validations, software design verification and traceability, software configuration management, tool validations and software integrations.
• You will support post‑market activities related to software anomalies, risk assessments and CAPA activities (if applicable).
• You are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables.
• You will assess the impact of change control to ensure no adverse impact on product performance and maintain compliance.
• You will effectively communicate with the broader Dexcom team and upper‑level management on plans, status of tasks, project progress and challenges.
• You will assume and perform other duties as assigned.

• You have experience working with software mobile applications.
• You bring medical device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971.
• Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development and Waterfall Model.
• Your software quality or engineering experience in requirements analysis, design/development, product integration and test.
• Your proficiency to interpret software design and code to verify implementation of requirements.
• You have software development and/or software test experience.
• Your ability to understand complex tasks and goals and drive projects to completion with limited supervision.
• Your ability to communicate and present to all levels of management.
• Nice to have knowledge of cybersecurity.
• Nice to have ASQ Certified Software Quality Engineer (CSQE) certification or equivalent.

• A front‑row seat to life‑changing CGM technology. Learn about our brave…