Senior Product Surveillance Engineer – Software QA

Dexcom

. Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate, document, and resolve software- and device-related postmarket issues .

Posted 9/22/2026full-timeUnited StatesSenior💰 $95,900 - $159,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software quality engineering, regulatory compliance, and risk management within the medical device industry. Capable of conducting thorough investigations and translating insights into actionable improvements for product performance and patient safety.

Highest-signal resume keywords

Software Quality EngineeringRegulatory ComplianceRisk Management PrinciplesStructured Problem-Solving TechniquesData Analysis and Interpretation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisSoftware Risk AssessmentsComplaint Investigation ProcessesEngineering StudiesTechnical Documentation

Soft Skills

Excellent CommunicationCollaboration Skills

Tools & Technologies

Cloud-Based PlatformsDistributed SystemsCybersecurity FundamentalsData-Driven Applications

Industry Keywords

FDA 21 CFR Part 820IEC 62304ISO 13485ISO 14971EU MDR

Tech Stack

Tools & technologies

CloudCyber SecurityDistributed Systems

About the role

Key responsibilities & impact

Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate, document, and resolve software- and device-related postmarket issues
Drive development and continuous improvement of complaint investigation processes aligned with software risk management activities
Develop and maintain deep understanding of Dexcom’s software ecosystem and technical architecture
Evaluate product performance, investigate anomalies, and identify opportunities for continuous improvement
Conduct investigations and engineering studies using structured problem-solving methodologies, statistical analysis, and industry-standard tools
Analyze, synthesize, and communicate investigation outcomes and recommendations to technical and non-technical stakeholders
Contribute to CAPA, Health Hazard Evaluations, and other quality system activities
Perform software-focused risk assessments related to product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends
Translate postmarket insights into improvements to product performance, user experience, and patient safety

Requirements

What you’ll need

Bachelor’s degree in a technical discipline and 5–8 years related experience, or Master’s degree and 2–5 years equivalent industry experience, or PhD and 0–2 years experience
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
Strong understanding of software risk management principles and methodologies
Excellent communication and collaboration skills
Working knowledge of cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications
Ability to apply engineering fundamentals and structured problem-solving techniques
Experience interpreting data, identifying trends, and translating findings into actionable recommendations
Ability to balance technical depth with business impact
Travel required: 0–5%

Benefits

Comp & perks

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