Sr Manager SW Design Quality Engineering

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.

Job Description
* This is a flex/hybrid role / Must live in Pacific Time Zone 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 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, Cyber Security, 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…