Staff SW QA Engineer
About The Position
Dexcom is seeking a Staff SW QA Engineer to provide technical leadership and subject-matter expertise in software quality, risk management, and software lifecycle compliance. The role supports scalable quality systems, risk management practices, and software compliance strategies that ensure product safety, effectiveness, and regulatory compliance. It partners with senior R&D engineering, quality, regulatory, clinical, cybersecurity, and business leaders to improve the software development lifecycle and quality across the product lifecycle. The engineer leads the application and improvement of software development and verification and validation processes, including risk management and software design controls for Class I/II exempt applications and components. The role leads quality initiatives across products and organizations, oversees software risk management, reviews and approves critical quality documentation, and drives improvements to quality systems, development practices, automation, verification, validation, and compliance. It also assesses regulations and industry trends, advises leadership on quality strategy, and mentors engineers and cross-functional teams. The position is remote from a home office for employees outside commuting distance of a Dexcom site; a hybrid environment may be available to those within commuting distance. Travel is required 15–25%.
Requirements
- Bachelor’s degree in a technical discipline and 8–12 years of related experience; or a master’s degree and 5–7 years of equivalent industry experience; or a PhD and 2–4 years of experience.
- Extensive medical device experience and 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 methodologies, including Agile, Waterfall, DevOps, continuous integration, continuous delivery (CI/CD), and test automation.
- Deep experience in 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 the 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.
Responsibilities
- Serve as a technical leader and subject-matter expert for software quality, risk management, and software lifecycle compliance.
- Lead the application, compliance, and continuous improvement of software development and verification and validation processes, including risk management and software design controls for Class I/II exempt applications and 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 involving ALM, SCM, and PLM systems supporting the SDLC as defined by IEC 62304.
- 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 lifecycle documentation, risk artifacts, V&V protocols, and design history file content.
- Drive organizational improvements in software quality systems, development practices, automation, verification, validation, and compliance processes.
- Evaluate emerging regulations, standards, and industry trends and assess their impact on existing and future products.
- Collaborate with senior leadership to define quality strategies that support business objectives and product roadmaps, including right-sized QMS applications based on IEC 62304 software classification.
- 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.
- Perform other duties as assigned.
Benefits
- Full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Career development through in-house learning programs and/or qualified tuition reimbursement.
- Opportunity to work with life-changing CGM technology at an innovative, industry-leading organization.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
