Senior Software QA Engineer, Medical Device Postmarket

Dexcom Inc.; Northern (KY); Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

A front row seat to CGM technology

Comprehensive benefits program

Global growth opportunities

Career development programs

Innovative organization

Job summary

Dexcom Inc. seeks a Postmarket Investigations professional to help bridge real-world product performance with continuous improvement. You will investigate software- and device-related postmarket issues, lead root-cause analyses, and drive CAPA and risk assessments across R&D, Quality, and Regulatory teams.

You will apply structured problem-solving, analyze data trends, and communicate findings to technical and non-technical stakeholders to support patient safety and regulatory compliance.

Qualifications

• Knowledge of medical device quality systems and regulatory requirements (FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR)
• Experience in software quality engineering through product lifecycle
• Strong software risk management principles and regulatory-aligned decision-making
• Excellent communication and collaboration across technical and non-technical stakeholders
• Knowledge of cloud-based platforms, distributed systems, cybersecurity, and data-driven apps

Responsibilities

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate postmarket issues
• Develop and improve complaint investigation processes aligned with risk management activities
• Understand Dexcom’s software ecosystem to evaluate product performance and identify improvements
• Apply structured problem-solving and data-driven approaches to investigations and root-cause analysis
• Communicate investigation outcomes to stakeholders with actionable recommendations
• Contribute to postmarket quality processes (CAPA, HHEs, quality system activities)
• Perform software-focused risk assessments on product anomalies and cybersecurity vulnerabilities
• Translate postmarket insights into product and patient-safety improvements

Skills

Medical device quality systems

Regulatory requirements

Software risk management

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in technical discipline

Master’s degree in technical discipline

PhD (optional)

Job description

Dexcom Inc. seeks a Postmarket Investigations professional to help bridge real-world product performance with continuous improvement. You will investigate software- and device-related postmarket issues, lead root-cause analyses, and drive CAPA and risk assessments across R&D, Quality, and Regulatory teams.

You will apply structured problem-solving, analyze data trends, and communicate findings to technical and non-technical stakeholders to support patient safety and regulatory compliance.