Staff SW QA Engineer

About this role

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:  

Provides technical   expertise   for software quality assurance activities , including risk management activities following ISO 14971 .    Supports   the development and implementation of scalable quality systems, risk management practices, and software compliance strategies that ensure product safety, effectiveness, and regulatory compliance. Partners with senior   R&D   engineering, quality, regulatory, clinical, cybersecurity, and business leaders to drive continuous improvement s to SDLC , and quality excellence throughout the product lifecycle. Influences organizational quality strategy and serves as a recognized subject matter expert in   software quality.  

Where you come in:   

• You will serve as a technical leader and subject matter expert for software quality, risk management, software lifecycle compliance activities .  

• You will lead the effective application, compliance, and continuous improvement of software development and   V&V   processes, including:   Risk Management, Software Design Controls for Class I/II Exempt Applications & Components

• You will lead complex software quality initiatives spanning multiple products, programs, and functional organizations.  

• You will lead risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues.  

• You will support   digital transformation initiatives (ALM, SCM, PLM) to evolve use of electronic systems supporting SDLC as defined   per   IEC62304 .    

• You will provide technical oversight and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis.  

• You will review and approve critical quality deliverables, including software development lifecycle documentation, risk artifacts,   V&V   protocols, and design history file content.  

• You will drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes.  

• You will evaluate emerging regulations, standards, and industry trends and assess impact   to   existing and future products.  

• You will collaborate with senior leadership to define quality strategies supporting business   objectives   and product roadmaps , implementing   a right -sized QMS   applications based on Software Classification per IEC62304.  

• You will mentor and provide technical leadership to software quality engineers and cross-functional development teams.  

• You will influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations.  

• You will assume and perform other duties as assigned .  

What makes you successful:   

• You have extensive medical device   experience   demonstrated   expertise   in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements.  

• You have advanced   knowledge of software development lifecycle processes and software development methodologies including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery   (CI/CD) , and Test Automation.  

• You have deep experience with software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities.  

• You have advanced understanding of software risk management principles, methodologies, and regulatory expectations.  

• You have demonstrated ability to influence organizational direction and lead cross-functional initiatives without direct authority.  

• You have strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms.  

• You have experience supporting regulatory inspections and direct interactions with FDA, notified bodies, and external auditors.  

• You have exceptional written, verbal, and executive-level communication skills.  

• You have the ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion.  

• You have demonstrated   success   mentoring engineers and developing organizational quality capabilities.  

What   you’ll   get :  

• A front row seat to   life changing   CGM technology.   Learn about our brave #dexcomwarriors community .  

• A   full and   c omprehensive benefit s   progra m .  

• Growth opportunities on a global scale.  

• Access to   career development through in-house learning programs and/or   qualified   tuition reimbursemen t.  

• A n   exciting   and   innovative ,   industry - leading organization   committed to our employees ,   customers , and the

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