Sr Product Surveillance Engineer - Software QA

Dexcom; San Diego (CA); On-site; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Growth opportunities

Tuition reimbursement

Job summary

Dexcom is seeking a qualified software quality professional to join the Postmarket Investigations team in San Diego. You will collaborate with Regulatory Affairs, Quality, R&D, Clinical, and Process Engineering to investigate postmarket issues and improve complaint processes.

You will analyze product performance, apply risk-based decision making, and translate findings into actionable improvements for safety and reliability.

Qualifications

• Bachelor’s degree in a technical discipline or equivalent experience.
• Experience with software quality engineering across the full product lifecycle.
• Knowledge of medical device quality systems and regulatory requirements.

Responsibilities

• Collaborate with Regulatory Affairs, Quality, R&D, Clinical, and Process Engineering to investigate postmarket issues.
• Drive development and improvement of complaint investigation processes aligned with risk management activities.
• Develop understanding of the Dexcom software ecosystem to evaluate performance and identify improvements.
• Apply structured problem-solving and data-driven methods to investigations and root-cause analyses.
• Summarize investigation outcomes for technical and non-technical stakeholders and inform decisions.
• Contribute to CAPA, Health Hazard Evaluations, and other quality system activities postmarket.

Skills

Regulatory knowledge

Software quality engineering

Software risk management

Data analysis

Root cause analysis

Cross-functional collaboration

Communication skills

Cloud/distributed systems knowledge

Education

Bachelor’s degree in a technical discipline

Master’s degree

PhD

Job description

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

Meet The Team

At Dexcom, the Postmarket Investigations team serves as a critical link between real-world product performance and continuous product improvement. As part of the Customer Advocacy organization, we assess postmarket feedback and product data to ensure learnings are integrated into future product enhancements. This role has a direct impact on patient safety, product reliability, and regulatory compliance through partnership with teams across R&D, Quality, and Commercial Operations. Our team values technical excellence, accountability, and continuous learning, while fostering a collaborative and supportive environment. Team members have the unique opportunity to drive quality improvements, influence key business processes, and contribute to technologies that empower people to take control of their health.

Where You Come In

• 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.

What Makes You Successful

• You have 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.
• You have experience supporting software quality engineering activities throughout the product lifecycle, including requirements, architecture, design, development, verification, validation, release, and postmarket surveillance.
• You have 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.
• You have excellent communication and collaboration skills, with the ability to effectively convey complex technical concepts to both technical and non-technical stakeholders across the organization.
• You have working knowledge of modern software technologies, including cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications.
• You have proven ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive effective corrective actions.
• You have strong analytical mindset with experience interpreting data, identifying trends, and translating findings into actionable recommendations.
• You have the ability to balance technical depth with business impact, driving decisions that support product quality, patient safety, compliance, and customer experience.

What You’ll Get

• A front row seat to life changing CGM technology. Learn about our brave #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 our employees, customers, and the communities we serve.

Travel Required

• 0-5%

Experience And Education Requirements

• 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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

AI in Hiring Notice

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary

$95,900.00 - $159,900.00

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