1 day ago
Remote, United StatesMid Level
H1B sponsor
Base Salary
$79k - $132k/yr
Responsibilities
- Participate as a core member of the R&D Quality Assurance Engineering team.
- Provide guidance on IEC 62304, 21 CFR 820, ISO 14971, and other applicable regulations.
- Lead the application, compliance, and continuous improvement of software development and validation policies and practices.
- Provide technical guidance on requirements, risk management, software validation, design verification, traceability, configuration management, tool validation, and software integrations.
- Support post-market software anomaly investigations, risk assessments, and CAPA activities.
- Review, author, revise, and approve technical documentation, including design history files, procedures, protocols, reports, and software design-control deliverables.
- Assess change-control impacts to maintain product performance and compliance.
- Communicate plans, status, project progress, and challenges to cross-functional teams and management.
Requirements
- Bachelor’s degree in a technical discipline and 2–5 years of related experience, or a master’s degree and 0–2 years of equivalent experience.
- Experience with software mobile applications and medical-device software compliance.
- Knowledge of SDLC processes and Agile Software Development or Waterfall methodologies.
- Software quality or engineering experience in requirements analysis, design and development, product integration, and testing.
- Ability to interpret software design and code to verify implementation of requirements.
- Software development and/or software testing experience.
- Ability to drive projects to completion with limited supervision and communicate with all levels of management.
- Cybersecurity knowledge is preferred.
- ASQ Certified Software Quality Engineer certification or equivalent is preferred.
- Experience with Jama, Jira, Kettryx, and/or TestRail is preferred.
Benefits
- Comprehensive benefits program.
- Global growth opportunities and access to in-house learning programs or qualified tuition reimbursement.
- Innovative, industry-leading work focused on continuous glucose monitoring and improving health outcomes.
- Travel required: 0–5%.
Categories
About Dexcom
Dexcom designs and manufactures continuous glucose monitoring (CGM) systems for people with diabetes, combining wearable sensors with transmitters, mobile apps, and cloud data services. It sells devices and disposable sensors through pharmacies, durable medical equipment channels, and healthcare providers, often covered by insurance. Founded in 1999 and headquartered in San Diego, Dexcom is a public company traded on NASDAQ (DXCM).