Sr Product Surveillance Engineer - Software QA

About the Role

As part of Dexcom's Postmarket Investigations team within the Customer Advocacy organization, you will play a critical role in assessing postmarket feedback and product data to drive continuous product improvement. This position directly impacts patient safety, product reliability, and regulatory compliance through collaboration with cross-functional teams across R&D, Quality, and Commercial Operations.

Responsibilities

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate, document, and resolve 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.
• 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, enhancing product performance, user experience, and patient safety.

Qualifications

• Bachelor’s degree in a technical discipline with 5-8 years of related experience, or Master’s degree with 2-5 years of experience, or PhD with 0-2 years of experience.

Skills

• 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 global regulations.
• Experience supporting software quality engineering activities throughout the product lifecycle, from requirements to 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.
• Excellent communication and collaboration skills, with the ability to convey complex technical concepts to diverse audiences.
• Working knowledge of modern software technologies, including cloud-based platforms, distributed systems, cybersecurity fundamentals, and data-driven applications.
• Proven ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues and drive 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, supporting product quality, patient safety, compliance, and customer experience.

Pay

$95,900.00 - $159,900.00

Travel Required: 0-5%