Senior Software QA Engineer

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

📋 Description

• Collaborate with Regulatory Affairs, Quality Assurance, Research and Development, Clinical, and Process Engineering teams on software and device-related postmarket challenges.

• Lead the development and ongoing enhancement of complaint investigation processes that align with software risk management initiatives.

• Cultivate and maintain an in-depth understanding of Dexcom’s software ecosystem and its technical infrastructure.

• Assess product performance, explore anomalies, and pinpoint opportunities for continuous improvement.

• Conduct investigations and engineering analyses utilizing structured problem-solving, data-driven techniques, statistical analysis, and industry-standard tools.

• Analyze, synthesize, and relay investigation results and recommendations to both technical and non-technical stakeholders.

• Contribute to Corrective and Preventive Actions (CAPA), Health Hazard Evaluations, and other quality system processes.

• Execute software-focused risk evaluations concerning product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends.

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

⛳️ Requirements

• 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.

• Familiarity with medical device quality systems and regulatory standards, such as FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and other relevant global regulations.

• Proven experience supporting software quality engineering processes throughout the product lifecycle.

• Strong grasp of software risk management principles and methodologies.

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

• Experience employing engineering principles and structured problem-solving methods.

• Skilled in data interpretation, trend identification, and translating findings into actionable insights.

• Exceptional communication and collaboration abilities.

• Capability to balance technical expertise with business impact.

🏝️ Benefits

• A comprehensive and extensive benefits package.

• Opportunities for growth on a global level.

• Career development through internal learning programs and/or eligible tuition reimbursement.

• 0–5% travel requirement.