Dexcom · 1 day ago
Software QA Engineer 2
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), focused on improving human health. The Software QA Engineer 2 will provide guidance on software development processes and compliance with relevant regulations while collaborating with cross-functional teams to ensure quality assurance in software design and validation.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
You will actively participate as a core team member of the R&D Quality Assurance Engineering team
You will provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and other relevant regulations worldwide to the cross-functional teams
You will lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams
You will provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA
You will provide guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool validations and software integrations
You will support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)
You are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables
You will assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained
You will effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges
You will assume and perform other duties as assigned
Qualification
Required
Experience working with software mobile applications
Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971
Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model
Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
Proficiency to interpret software design and code to verify implementation of requirements
Software development and/or Software test experience
Ability to understand complex tasks and goals. Drive projects to completion with limited supervision
Ability to communicate and present to all levels of management
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years' equivalent experience
Preferred
Nice to have knowledge of Cyber Security
Nice to have ASQ Certified Software Quality Engineer (CSQE) certification or equivalent
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.
Company
Dexcom
Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.
H1B Sponsorship
Dexcom has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)
Funding
Current Stage
Public CompanyTotal Funding
$2.16BKey Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M
Leadership Team
Recent News
San Diego Union-Tribune
2026-01-08
The Motley Fool
2025-12-30
Company data provided by crunchbase