Dexcom
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed and to unlock information and insights that drive better health outcomes. 25 years later we have pioneered the industry, and we’re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health, delivering personalised, actionable insights aimed at solving important health challenges and continuing to improve human health.
Meet The Team The
Senior Manager, Software Quality Engineering
is responsible for leading all aspects of software quality assurance, including managing and mentoring the QA team. This role works closely with cross‑functional teams to ensure development, testing, and release of product software and supporting infrastructure comply with U.S. and international regulatory standards, oversees the partnerships component of the Quality Management System (QMS), and leads a dedicated team for that function.
Where You Come In
Leadership & Team Management: Align technology solutions with business objectives, ensure regulatory compliance, and provide mentorship to the Software QA and partnerships teams.
Quality Oversight: Manage the software development lifecycle (SDLC) and define key performance metrics for reporting to senior leadership.
Compliance & Standards: Ensure compliance with IEC 62304, FDA software validation principles, and cybersecurity guidance throughout the development process.
Documentation & Reporting: Prepare and present quality findings to executive management and R&D leadership; monitor and resolve ongoing issues.
Process Improvement: Collaborate with R&D, Operations, CyberSecurity, and V&V teams to maintain efficient, compliant development and testing processes.
Risk Management: Lead risk assessments, health hazard assessments and guide mitigation strategies; also support CAPAs as applicable.
Regulatory Support: Maintain validated states, review change control documentation, and present validation records during audits. Promote best practices in system design and development.
Design & Development Support: Participate in design reviews, assist with defining software inputs, and verify outputs against requirements.
Continuous Improvement: Identify compliance gaps, evaluate new regulations, and update procedures in collaboration with relevant departments. Support organization‑wide remediation efforts related to regulatory findings.
Other Duties: Perform additional responsibilities as assigned.
What Makes You Successful
At least 7 years in software QA or development for medical devices, including 5 years leading high‑performing teams.
Experience in Agile environments with strong knowledge of automated testing and regulatory standards such as IEC 62304 and FDA guidance.
Deep understanding of Quality, Regulatory, and R&D systems within medical devices or other highly regulated industries.
Exceptional communication, stakeholder management, and presentation skills.
Drive change by analysing business processes, designing improvements, and empowering users through training.
Clear, compelling documentation and presentations that make complex strategies and technical concepts easy to understand.
Positive, results‑driven team player bringing logic and collaboration to every challenge.
Embraces innovation: quick learning, adaptability to new technologies, and juggling multiple projects with ease.
Works independently while meeting deadlines and delivering exceptional results.
Preferred Qualifications
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.
Experience with Mobile application development.
BI/AI platform experience is a plus.
What You’ll Get
A front‑row seat to life‑changing CGM technology; learn about the brave #dexcomwarriors community.
A 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, industry‑leading organization committed to employees, customers, and the communities we serve.
Experience And Education Requirements
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.
Flex Workplace Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120 km).
Travel Required
0‑5%
Salary
$149,000.00 – $248,300.00
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s ADA statement is available upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.
#J-18808-Ljbffr
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed and to unlock information and insights that drive better health outcomes. 25 years later we have pioneered the industry, and we’re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health, delivering personalised, actionable insights aimed at solving important health challenges and continuing to improve human health.
Meet The Team The
Senior Manager, Software Quality Engineering
is responsible for leading all aspects of software quality assurance, including managing and mentoring the QA team. This role works closely with cross‑functional teams to ensure development, testing, and release of product software and supporting infrastructure comply with U.S. and international regulatory standards, oversees the partnerships component of the Quality Management System (QMS), and leads a dedicated team for that function.
Where You Come In
Leadership & Team Management: Align technology solutions with business objectives, ensure regulatory compliance, and provide mentorship to the Software QA and partnerships teams.
Quality Oversight: Manage the software development lifecycle (SDLC) and define key performance metrics for reporting to senior leadership.
Compliance & Standards: Ensure compliance with IEC 62304, FDA software validation principles, and cybersecurity guidance throughout the development process.
Documentation & Reporting: Prepare and present quality findings to executive management and R&D leadership; monitor and resolve ongoing issues.
Process Improvement: Collaborate with R&D, Operations, CyberSecurity, and V&V teams to maintain efficient, compliant development and testing processes.
Risk Management: Lead risk assessments, health hazard assessments and guide mitigation strategies; also support CAPAs as applicable.
Regulatory Support: Maintain validated states, review change control documentation, and present validation records during audits. Promote best practices in system design and development.
Design & Development Support: Participate in design reviews, assist with defining software inputs, and verify outputs against requirements.
Continuous Improvement: Identify compliance gaps, evaluate new regulations, and update procedures in collaboration with relevant departments. Support organization‑wide remediation efforts related to regulatory findings.
Other Duties: Perform additional responsibilities as assigned.
What Makes You Successful
At least 7 years in software QA or development for medical devices, including 5 years leading high‑performing teams.
Experience in Agile environments with strong knowledge of automated testing and regulatory standards such as IEC 62304 and FDA guidance.
Deep understanding of Quality, Regulatory, and R&D systems within medical devices or other highly regulated industries.
Exceptional communication, stakeholder management, and presentation skills.
Drive change by analysing business processes, designing improvements, and empowering users through training.
Clear, compelling documentation and presentations that make complex strategies and technical concepts easy to understand.
Positive, results‑driven team player bringing logic and collaboration to every challenge.
Embraces innovation: quick learning, adaptability to new technologies, and juggling multiple projects with ease.
Works independently while meeting deadlines and delivering exceptional results.
Preferred Qualifications
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.
Experience with Mobile application development.
BI/AI platform experience is a plus.
What You’ll Get
A front‑row seat to life‑changing CGM technology; learn about the brave #dexcomwarriors community.
A 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, industry‑leading organization committed to employees, customers, and the communities we serve.
Experience And Education Requirements
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.
Flex Workplace Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120 km).
Travel Required
0‑5%
Salary
$149,000.00 – $248,300.00
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s ADA statement is available upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.
#J-18808-Ljbffr