Postmarket Hardware Quality Engineer

Dexcom; Mesa (AZ); On-site; USD 91,000 - 152,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Tuition reimbursement

Job summary

Dexcom seeks a Postmarket Investigations specialist to support software- and device-related postmarket issues. You will collaborate across Regulatory, Quality, R&D, Clinical, and Process Engineering to drive investigations and improve complaint handling.

You will apply data-driven root-cause analysis, lead risk assessments, and ensure regulatory alignment with CAPA and vigilance requirements. This role emphasizes collaboration, safety, and continuous product improvement.

Qualifications

• Bachelor's degree in a technical field required.
• 2–5 years related experience or Master’s with 0–2 years equivalent.
• Knowledge of postmarket surveillance, CAPA, vigilance reporting.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR.

Responsibilities

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate postmarket issues.
• Drive the development and improvement of complaint investigation processes with risk management alignment.
• Develop and maintain a deep understanding of Dexcom hardware ecosystem to evaluate performance and anomalies.
• Apply structured problem-solving methods and data-driven approaches for investigations and root-cause analysis.
• Communicate investigation outcomes to technical and non-technical stakeholders with clear recommendations.
• Contribute to postmarket quality processes including CAPA and Health Hazard Evaluations.
• Perform hardware-focused risk assessments related to product anomalies and regulatory compliance.
• Partner with product development and quality teams to translate insights into actionable improvements.

Skills

Regulatory knowledge

Quality systems

Postmarket surveillance

Root cause analysis

Cross-functional collaboration

Communication

Education

Bachelor's degree in a technical discipline

Tools

Statistical analysis

Job description

Dexcom seeks a Postmarket Investigations specialist to support software- and device-related postmarket issues. You will collaborate across Regulatory, Quality, R&D, Clinical, and Process Engineering to drive investigations and improve complaint handling.

You will apply data-driven root-cause analysis, lead risk assessments, and ensure regulatory alignment with CAPA and vigilance requirements. This role emphasizes collaboration, safety, and continuous product improvement.