Sr Manager Software QA Engineering jobs in United States
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Dexcom · 1 month ago

Sr Manager Software QA Engineering

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Senior Manager, Software Quality Engineering is responsible for leading all aspects of software quality assurance, managing the QA team, and ensuring compliance with regulatory standards during the software development lifecycle.

DiabetesHealth DiagnosticsMedical DeviceSensor
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H1B Sponsor Likelynote

Responsibilities

Align technology solutions with business objectives, ensure regulatory compliance, and provide mentorship to the Software QA and partnerships teams
Manage the software development lifecycle (SDLC) and define key performance metrics for reporting to senior leadership
Ensure compliance with IEC 62304, FDA software validation principles, and cybersecurity guidance throughout the development process
Prepare and present quality findings to executive management and R&D leadership; monitor and resolve ongoing issues
Collaborate with R&D, Operations, CyberSecurity, and V&V teams to maintain efficient, compliant development and testing processes
Lead risk assessments, health Hazard assessments and guide mitigation strategies. Also support CAPAs as applicable
Maintain validated states, review change control documentation, and present validation records during audits. Promote best practices in system design and development
Participate in design reviews, assist with defining software inputs, and verify outputs against requirements
Identify compliance gaps, evaluate new regulations, and update procedures in collaboration with relevant departments. Support organization-wide remediation efforts related to regulatory findings
Perform additional responsibilities as assigned

Qualification

Software QA ManagementRegulatory ComplianceAgile MethodologiesAutomated TestingIEC 62304FDA RegulationsCloud PlatformsStakeholder ManagementProcess ImprovementRisk ManagementLeadership SkillsDocumentation SkillsCommunication SkillsTeam CollaborationProblem Solving

Required

At least 7 years in software QA or development for medical devices, including 5 years leading high-performing teams
Strong knowledge of automated testing and regulatory standards like IEC 62304 and FDA guidance
Ability to manage teams, processes, and compliance in a fast-paced, regulated setting
Deep understanding of Quality, Regulatory, and R&D systems within medical devices or other highly regulated industries
Strong leadership and stakeholder management skills
Ability to analyze business processes, design improvements, and empower users through training
Ability to craft clear, compelling documentation and presentations
Positive, results-driven team player who brings logic and collaboration to every challenge
Ability to learn quickly, adapt to new technologies, and juggle multiple projects with ease
Ability to work independently while meeting deadlines and delivering exceptional results
Typically requires a Bachelor's degree, preferably in an Engineering or STEM discipline, with 13+ years of industry experience
5-8 years of previous people management experience

Preferred

Proficiency in modern programming languages
Experience with cloud platforms (Azure, AWS, Google Cloud) and big data tools
Familiarity with mobile and wearable software development
Expertise in FDA regulations (21 CFR Part 11 & 820) and cybersecurity guidance
BI/AI Platform Experience is a plus
Experience with Mobile application development

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