Remote Hardware Engineer II – Postmarket Quality & Insights

Dexcom; California (MO); Hybrid; USD 91,000 - 152,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Career development

Job summary

Dexcom is seeking a Postmarket Investigations professional to support the Customer Advocacy organization. You will collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate software- and device-related postmarket issues.

You will lead structured problem‑solving, perform risk assessments, and translate insights into product improvements while ensuring patient safety and regulatory compliance.

Qualifications

• Knowledge of medical device quality systems and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR).
• Experience with hardware quality and reliability activities across product lifecycle.
• Strong analytical mindset with data interpretation and trend identification.

Responsibilities

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate and resolve postmarket issues.
• Drive development and continuous improvement of complaint investigation processes aligned with risk management activities.
• Develop deep understanding of Dexcom’s hardware ecosystem to evaluate performance and identify improvement opportunities.
• Apply structured problem-solving and data-driven approaches to lead investigations and identify root causes.
• Communicate investigation outcomes to stakeholders and support informed decision-making across the organization.
• Contribute to postmarket quality processes (CAPA, HHEs) and risk assessments.
• Perform hardware-focused risk assessments related to product anomalies and clinical impact.
• Translate postmarket insights into actionable improvements with product development and quality teams.

Skills

Postmarket investigations

Regulatory compliance

Hardware quality

Risk management

Data analysis

Cross‑functional collaboration

Education

Bachelor’s degree in a technical discipline

Tools

Statistical analysis tools

Job description

Dexcom is seeking a Postmarket Investigations professional to support the Customer Advocacy organization. You will collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate software- and device-related postmarket issues.

You will lead structured problem‑solving, perform risk assessments, and translate insights into product improvements while ensuring patient safety and regulatory compliance.