Hardware Engineer 2

Dexcom is a global leader in continuous glucose monitoring and biosensing technology focused on improving human health. The Hardware Engineer 2 will support postmarket investigations of software- and device-related issues, develop complaint investigation processes, conduct hardware risk assessments and root-cause analyses, and translate findings into product, quality, and patient-safety improvements.

Responsibilities:

• 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

Requirements:

• • 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, including electromechanical systems, electronics, sensors, materials, reliability engineering, manufacturing processes, and failure analysis techniques used in medical device development and support
• • You have proven ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive effective corrective actions
• • You have strong analytical mindset with experience interpreting data, identifying trends, and translating findings into actionable recommendations
• • You have the ability to balance technical depth with business impact, driving decisions that support product quality, patient safety, compliance, and customer experience
• • You have experience performing postmarket surveillance activities, including complaint investigations, trending and signal detection, reliability analysis, risk assessments, CAPA support, periodic product reviews, and communication of field performance insights to internal and external stakeholders
• • Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2 - 5 years related experience or Master's degree and 0-2 years' equivalent experience
• • You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km)
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