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. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the Team:
TheSenior Manager, Software QualityEngineeringis responsible forleading all aspects of software quality assurance, includingmanagingand mentoring the QA team. This role works closely with cross-functional teams to ensure that the development, testing, and release of product software and supporting infrastructurecomply withU.S. and international regulatory standards. Additionally, this position oversees the partnershipscomponentof the Quality Management System (QMS) andleadsa dedicated team for that function.
Where you Come in:
Leadership & Team Management:Align technology solutions with businessobjectives, 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;monitorand resolve ongoing issues.
Process Improvement:Collaborate with R&D, Operations,CyberSecurity, and V&V teams tomaintainefficient, compliant development and testing processes.
Risk Management:Lead risk assessments, health Hazardassessmentsand guide mitigation strategies. Also support CAPAs as applicable.
Regulatory Support:Maintainvalidated states, review change control documentation, and present validation records during audits. Promote best practices in system design and development.
Design & Development Support:Participatein design reviews,assistwith defining software inputs, and verify outputs against requirements.
Continuous Improvement:Identifycompliance gaps, evaluate new regulations, and update procedures in collaboration with relevant departments. Support organization-wide remediation efforts related to regulatory findings.
Other Duties:Performadditionalresponsibilities as assigned.
What makes you successful:
Bring yourexpertiseto the forefront with at least 7 years in software QA or development for medical devices, including 5 years leading high-performing teams
Thrive in Agile environments with strong knowledge of automated testing and regulatory standards like IEC 62304 and FDA guidance
Leads with confidence, manage teams, processes, and compliance in a fast-paced, regulated setting
Apply your deep understanding of Quality, Regulatory, and R&D systems within medical devices or other highly regulated industries
Communicate with impact, strong leadership and stakeholder management skills are essential
Drive change by analyzing business processes, designing improvements, and empowering users through training
Craft clear, compelling documentation and presentations that make complex strategies and technical concepts easy to understand
Be a positive, results-driven team player who brings logic and collaboration to every challenge
Embrace innovation- Ability to learn quickly, adapt tonew technologies, and juggle multiple projects with ease
Work independently while meeting deadlines and delivering exceptional results
Preferred Qualifications
Proficiencyin modern programming languages.
Experience with cloud platforms (Azure, AWS, Google Cloud) and big data tools.
Familiarity with mobile and wearable software development.
Expertisein FDA regulations (21 CFR Part 11 & 820) and cybersecurity guidance.
BI/AI Platform Experience is a plus
Experience with Mobile application development
Whatyou’llget:
A front row seat to life changing CGM technology.Learn about our brave #dexcomwarriors community.
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.
Experience and Education Requirements:
Typically requires aBachelor’sdegree, preferably in an Engineering
dexcom