Actively participates as a core team member of the R&D Quality Assurance Engineering team.
Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide.
Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including: Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management.
Provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations.
Reviews and approves all software design control deliverables.
Support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable).
Lead and support R&D SW Design Assurance efforts including continuous improvement opportunities for products and processes.
Responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc.
Assesses the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained.
Effectively communicates with the broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges.
Assumes and performs other duties as assigned.

Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485
Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
Ability to interpret software design and code to verify implementation of requirements
Software development and/or Software test experience
Ability to communicate and present to all levels of management.
Ability to understand complex tasks and goals.
Drive projects to completion with limited supervision.
Experience working with cloud-based systems.

A front row seat to life changing CGM technology.
Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Software QA Engineer

Key skills