Hardware Engineer 2 Job Mesa area,Arizona USA,Quality Assurance

Job Title

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.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions.

We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

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 hardware ecosystem 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 hardware-focused risk assessments related to product anomalies, clinical impact, 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, ISO 13485, ISO 14971, EU MDR, and other applicable global regulations, with a strong understanding of postmarket surveillance, complaint handling, CAPA, and vigilance reporting requirements.
You have experience supporting hardware quality and reliability activities throughout the product lifecycle, including design and development, verification and validation, field performance monitoring, and postmarket surveillance.
You have strong understanding of hardware risk management principles and methodologies, with the ability to evaluate and mitigate product risks, assess field safety signals, and 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 hardware engineering principles and technologies,…