24 hours ago
Bengaluru, IndiaSenior
Responsibilities
- Provide quality and regulatory guidance to cross-functional software teams on IEC 62304, FDA 21 CFR Part 820, and other applicable regulations.
- Lead the application, compliance, and continuous improvement of software development and validation policies, procedures, and practices.
- Provide technical guidance on equipment, software, product, and process requirements and drive risk-management deliverables including SHA and design and process FMEA.
- Guide software design and test teams on system validation, software design verification, traceability, configuration management, tool validation, and software integrations.
- Support post-market activities involving software anomalies, risk assessments, and CAPA activities.
- Review, author, revise, and approve technical documentation including design history files, standard operating procedures, protocols, reports, and software design-control deliverables.
- Assess change-control impacts to maintain product performance and compliance.
- Communicate plans, task status, project progress, and challenges to broad teams and upper-level management.
Requirements
- Typically requires a bachelor's degree in a technical discipline and 5–8 years of related experience, or a master's degree and 2–5 years of equivalent industry experience, or a PhD and 0–2 years of experience.
- Experience working with software mobile applications and web APIs.
- Medical-device experience with FDA 21 CFR Part 820, IEC 62304, and ISO 13485 compliance requirements.
- Knowledge and experience with SDLC processes and software development methodologies such as Agile Software Development and the Waterfall Model.
- Experience in software quality or engineering across 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.
- Ability to understand complex tasks, drive projects to completion with limited supervision, and communicate with all levels of management.
- Cybersecurity experience is preferred.
- ASQ Certified Software Quality Engineer (CSQE) certification is preferred.
Benefits
- Full and comprehensive benefits program.
- Global growth opportunities and access to in-house career development programs and qualified tuition reimbursement.
- Opportunity to work on continuous glucose monitoring technology in an innovative, industry-leading health technology organization.
- Travel required 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).