Sr Software QA Engineer

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring. The Sr Software QA Engineer will collaborate with cross-functional teams to investigate and resolve software-related postmarket issues, ensuring product reliability and regulatory compliance.

Responsibilities:

• You will collaborate with cross-functional partners including Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to support the investigation, documentation, and resolution of software- and device-related postmarket issues
• You will drive the development and continuous improvement of complaint investigation processes, ensuring alignment with software risk management activities such as hazard analysis, DFMEA, PFMEA, and product risk assessments
• You will develop and maintain a deep understanding of Dexcom’s software ecosystem and technical architecture to effectively evaluate product performance, investigate anomalies, and identify opportunities for continuous improvement
• You will apply structured problem-solving methodologies and data-driven approaches to conduct investigations, lead engineering studies, and identify root causes using statistical analysis and industry-standard tools
• You will analyze, synthesize, and communicate investigation outcomes to technical and non-technical stakeholders, providing clear recommendations and supporting informed decision-making across the organization
• You will contribute to postmarket quality processes, including CAPA, Health Hazard Evaluations (HHEs), and other quality system activities, ensuring thorough assessment of product performance and risk
• You will perform software-focused risk assessments related to product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends, helping to ensure product safety, reliability, and regulatory compliance
• You will partner with product development and quality teams to translate postmarket insights into actionable improvements, driving enhancements to product performance, user experience, and patient safety

Requirements:

• Demonstrated knowledge of medical device quality systems and regulatory requirements, including FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and other applicable global regulations
• Experience supporting software quality engineering activities throughout the product lifecycle, including requirements, architecture, design, development, verification, validation, release, and postmarket surveillance
• Strong understanding of software risk management principles and methodologies, with the ability to apply risk-based decision-making in alignment with regulatory expectations and industry best practices
• Excellent communication and collaboration skills, with the ability to effectively convey complex technical concepts to both technical and non-technical stakeholders across the organization
• Working knowledge of modern software technologies, including cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications
• Proven ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive effective corrective actions
• Strong analytical mindset with experience interpreting data, identifying trends, and translating findings into actionable recommendations
• Ability to balance technical depth with business impact, driving decisions that support product quality, patient safety, compliance, and customer experience
• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience