Software QA Engineer 2 jobs in United States
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Dexcom · 1 month ago

Software QA Engineer 2

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They are seeking a Software QA Engineer 2 to provide guidance on regulatory compliance and ensure the quality of software development processes within the R&D Quality Assurance Engineering team.

DiabetesHealth DiagnosticsMedical DeviceSensor
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H1B Sponsor Likelynote

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

Medical Device experienceIEC 62304 complianceFDA 21 CFR Part 820SDLC processesSoftware Quality EngineeringAgile Software DevelopmentSoftware development experienceSoftware test experienceCyber Security knowledgeASQ CSQE certificationCommunication skills

Required

You have experience working with software mobile applications
You bring Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971
Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model
Your Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
Your proficiency to interpret software design and code to verify implementation of requirements
You have Software development and/or Software test experience
Your ability to understand complex tasks and goals. Drive projects to completion with limited supervision
Your 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 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 Company
Total Funding
$2.16B
Key Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M

Leadership Team

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Jacob Leach
Chief Operating Officer
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Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
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Company data provided by crunchbase