Dexcom Deutschland GmbH · 2 days ago
Sr Manager Software QA Engineering
San Diego, CA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$149K/yr - $248K/yr
13+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to improve health outcomes. The Senior Manager, Software Quality Engineering is responsible for leading software quality assurance efforts, managing the QA team, and ensuring compliance with regulatory standards throughout the software development lifecycle.
Medical Device
Responsibilities
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
Qualification
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 Deutschland GmbH
Die 1999 gegründete Dexcom, Inc.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase