* This is a flex/hybrid role / Must live in Pacific Time ZoneMeet 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 that the development, testing, and release of product software and supporting infrastructure comply with U.S. and international regulatory standards. Additionally, this position 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: - Bring your expertise to 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 to new technologies, and juggle multiple projects with ease
- Work 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.
- BI/AI Platform Experience is a plus
- Experience with Mobile application development
What you'll get: - 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 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/120km). Travel Required: Salary:
$149,000.00 - $248,300.00
