Staff SW QA Engineer

Dexcom • Remote California, CA

5d • $116,600 - $194,400 • Remote

About The Position

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. 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 improvements to SDLC, and quality excellence throughout the product lifecycle. Influences organizational quality strategy and serves as a recognized subject matter expert in software quality.

Requirements

• 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.
• Advanced knowledge of software development lifecycle processes and software development methodologies including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation.
• Deep experience with software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities.
• Advanced understanding of software risk management principles, methodologies, and regulatory expectations.
• Demonstrated ability to influence organizational direction and lead cross-functional initiatives without direct authority.
• Strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms.
• Experience supporting regulatory inspections and direct interactions with FDA, notified bodies, and external auditors.
• Exceptional written, verbal, and executive-level communication skills.
• Ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion.
• Demonstrated success mentoring engineers and developing organizational quality capabilities.
• Typically requires a Bachelor’s Degree in a technical discipline and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.

Responsibilities

• Serve as a technical leader and subject matter expert for software quality, risk management, software lifecycle compliance activities.
• 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
• Lead complex software quality initiatives spanning multiple products, programs, and functional organizations.
• Lead risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues.
• Support digital transformation initiatives (ALM, SCM, PLM) to evolve use of electronic systems supporting SDLC as defined per IEC62304.
• Provide technical oversight and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis.
• Review and approve critical quality deliverables, including software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content.
• Drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes.
• Evaluate emerging regulations, standards, and industry trends and assess impact to existing and future products.
• 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.
• Mentor and provide technical leadership to software quality engineers and cross-functional development teams.
• Influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations.
• Assume and perform other duties as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior