Overview
Software QA Engineer 2 on Dexcom’s R&D Quality Assurance Engineering team, supporting software quality and design assurance for medical device software across global regulations.
What you'll do
- Act as a core team member of the R&D Quality Assurance Engineering team.
- Provide guidance to cross-functional teams on IEC 62304, 21 CFR 820, ISO 14971, and related regulations.
- Lead effective application, compliance, and continuous improvement of software development and validation policies and practices.
- Drive risk management deliverables including SHA, design FMEA, and process FMEA.
- Guide software design and test activities for system validation, verification, traceability, configuration management, and tool validations.
- Support post-market activities including software anomaly handling, risk assessments, and CAPA (if applicable).
- Review, author, revise, and approve technical documentation such as design history file, SOPs, protocols, reports, and software design control deliverables.
What you'll need
- Experience working with software mobile applications.
- Medical device experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971.
- Knowledge of SDLC processes and software development methodologies such as Agile and Waterfall.
- Software quality or engineering experience in requirements analysis, design/development, product integration, and test.
- Ability to interpret software design and code to verify requirements implementation.
- Software development and/or software test experience.
- Proficiency to understand complex tasks, drive projects to completion with limited supervision, and communicate to management.
Details
- Work location: Remote - United States.
- Travel required: 0-5%.
Read the full description and apply on the company’s own careers page.
