Sr Software QA Engineer

Dexcom Corporation (NASDAQ: DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Founded 25 years ago with a mission to transform diabetes management, Dexcom is expanding its vision to empower people to take control of their health through personalized, actionable insights. The company is driven by passionate, ambitious individuals committed to improving human health on a global scale.

About the team

The Postmarket Investigations team at Dexcom serves as a critical link between real-world product performance and continuous product improvement. As part of the Customer Advocacy organization, the team assesses postmarket feedback and product data to integrate learnings into future enhancements. This role directly impacts patient safety, product reliability, and regulatory compliance through collaboration with R&D, Quality, and Commercial Operations. The team values technical excellence, accountability, and continuous learning in a collaborative environment.

Responsibilities

• 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.
• 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.
• Develop and maintain a deep understanding of Dexcom’s software ecosystem and technical architecture to evaluate product performance, investigate anomalies, and identify opportunities for continuous improvement.
• 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.
• Analyze, synthesize, and communicate investigation outcomes to technical and non-technical stakeholders, providing clear recommendations and supporting informed decision-making across the organization.
• Contribute to postmarket quality processes, including CAPA, Health Hazard Evaluations (HHEs), and other quality system activities, ensuring thorough assessment of product performance and risk.
• Perform software-focused risk assessments related to product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends to ensure product safety, reliability, and regulatory compliance.
• 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.
• 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.

Qualifications

Typically requires a Bachelor’s degree in a technical discipline and a minimum of 5-8 years of related experience, or a Master’s degree and 2-5 years of equivalent industry experience, or a PhD and 0-2 years of experience.

Benefits

• A front-row seat to life-changing CGM technology and the #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 employees, customers, and communities.

Pay

$95,900.00 - $159,900.00

Schedule

Travel required: 0-5%