[Hiring] Staff SW QA Engineer @Dexcom

Role Description

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.

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 the 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 their impact on 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.

Qualifications

• 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.

Benefits

• 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 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.

Remote Workplace

• Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
• If you reside within commuting distance of a Dexcom site (typically 75 miles/120km), a hybrid working environment may be available. Ask about our Flex workplace option.