17 hours ago
Bengaluru, IndiaEntry Level
Responsibilities
- Provide guidance on IEC 62304, FDA 21 CFR Part 820, and other worldwide software regulations.
- Lead the application, compliance, and continuous improvement of software development and validation policies, procedures, and practices.
- Guide teams on equipment, software, product, and process requirements and risk-management deliverables such as SHA and design/process FMEA.
- Support system validation, software design verification and traceability, configuration management, tool validation, and software integration activities.
- Support post-market software anomaly activities, risk assessments, and CAPA when applicable.
- 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, 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 working with software mobile applications.
- Medical-device experience involving FDA 21 CFR Part 820, IEC 62304, and ISO 13485 compliance.
- Knowledge of software development life-cycle processes and software development methodologies.
- Software quality or engineering experience in requirements analysis, design/development, product integration, and testing.
- Ability to interpret software design and code to verify implementation of requirements.
- Software development and/or software test experience.
- Experience with web APIs.
- Ability to understand complex tasks, work with limited supervision, drive projects to completion, and communicate with all levels of management.
- Cybersecurity experience is preferred.
- ASQ Certified Software Quality Engineer certification is preferred.
Benefits
- Full and comprehensive benefits program.
- Global growth opportunities and access to in-house learning programs and/or qualified tuition reimbursement.
- Opportunity to work on continuous glucose monitoring technology in an innovative, industry-leading organization.
- Travel required is 0–15%.
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).