Senior Software QA Engineer

This is a fully remote position, open to applicants in California.

📋 Description

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering on postmarket issues related to software and devices.

• Lead the development and ongoing enhancement of complaint investigation processes in alignment with software risk management activities.

• Cultivate and sustain a comprehensive understanding of Dexcom’s software ecosystem and its technical architecture.

• Assess product performance, investigate irregularities, and pinpoint opportunities for continuous improvement.

• Execute investigations and engineering studies utilizing structured problem-solving methodologies, statistical analysis, and industry-standard tools.

• Analyze, consolidate, and convey investigation results and recommendations to both technical and non-technical stakeholders.

• Contribute to CAPA, Health Hazard Evaluations, and various quality-system activities.

• Conduct software-centric risk assessments considering product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends.

• Transform postmarket insights into enhancements for product performance, user experience, and patient safety.

⛳️ Requirements

• Familiarity with medical device quality systems and regulatory standards, including FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, and EU MDR.

• A Bachelor’s degree in a technical field and 5–8 years of relevant experience, or a Master’s degree with 2–5 years of equivalent industry experience, or a PhD with 0–2 years of experience.

• Proven experience in supporting software quality engineering across requirements, architecture, design, development, verification, validation, release, and postmarket surveillance.

• Strong grasp of software risk management principles and methodologies.

• Capability to articulate complex technical concepts to both technical and non-technical audiences.

• Working knowledge of cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications.

• Proficiency in applying engineering fundamentals and structured problem-solving techniques to investigate complex issues, identify root causes, and implement corrective actions.

• Experience in data interpretation, trend identification, and translating findings into actionable recommendations.

• Ability to balance technical depth with business impact, product quality, patient safety, compliance, and customer experience.

• Willingness to travel 0–5%.

🏝️ Benefits

• A complete and comprehensive benefits package.

• Opportunities for growth on a global scale.

• Access to career development through internal learning programs and/or qualified tuition reimbursement.

• An innovative, industry-leading organization dedicated to employees, customers, and communities.

• Travel required: 0–5%.