Note: The job is a remote job and is open to candidates in USA. Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), focusing on improving human health through innovative technology. The Software QA Engineer 1 will provide technical support to ensure compliance with software development processes and quality standards, while collaborating with various cross-functional teams to enhance product development and defect prevention.
Responsibilities
- 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
Skills
- Typically requires a bachelor's degree in a technical discipline
- Minimum of 0-2 years of related experience
- 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
- 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
- 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
- ASQ Certified Software Quality Engineer (CSQE)
- Cyber Security experience
- Experience working with Cloud based infrastructure and systems that process, store and distribute large sets of data continuously
Benefits
- 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.
Company Overview
- Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management. It was founded in 1999, and is headquartered in San Diego, California, USA, with a workforce of 10001+ employees. Its website is http://www.dexcom.com.
Company H1B Sponsorship
- Dexcom has a track record of offering H1B sponsorships, with 54 in 2025, 41 in 2024, 67 in 2023, 75 in 2022, 49 in 2021, 36 in 2020. Please note that this does not guarantee sponsorship for this specific role.