1 day ago
Base Salary
$96k - $160k/yr
Responsibilities
- Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering teams on software- and device-related postmarket investigations.
- Develop and continuously improve complaint investigation processes aligned with software risk management activities.
- Evaluate product performance, investigate anomalies, conduct engineering studies, and identify root causes using structured and data-driven methods.
- Analyze and communicate investigation outcomes and recommendations to technical and non-technical stakeholders.
- Contribute to CAPA, Health Hazard Evaluations, and other postmarket quality-system activities.
- Perform software-focused risk assessments involving product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends.
- Translate postmarket insights into product, user-experience, reliability, and patient-safety improvements.
Requirements
- Bachelor’s degree in a technical discipline and 5–8 years of related experience, or a master’s degree and 2–5 years of equivalent industry experience, or a PhD and 0–2 years of experience.
- Knowledge of medical-device quality systems and regulatory requirements, including FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, and EU MDR.
- Experience supporting software quality engineering across requirements, architecture, design, development, verification, validation, release, and postmarket surveillance.
- Strong understanding of software risk management principles and risk-based decision-making.
- Experience applying engineering fundamentals, structured problem-solving, root-cause analysis, and corrective-action methods.
- Analytical ability to interpret data, identify trends, and produce actionable recommendations.
- Working knowledge of cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications.
- Strong communication and collaboration skills with technical and non-technical stakeholders.
Benefits
- Comprehensive benefits program.
- Global growth opportunities and access to in-house learning programs or qualified tuition reimbursement.
- Opportunity to work on life-changing continuous glucose monitoring technology.
- Travel required: 0–5%.
- Innovative, industry-leading organization focused on employees, customers, and communities.
Categories
About Dexcom
Dexcom designs and manufactures continuous glucose monitoring (CGM) systems for people with diabetes, combining wearable sensors with transmitters, mobile apps, and cloud data services. It sells devices and disposable sensors through pharmacies, durable medical equipment channels, and healthcare providers, often covered by insurance. Founded in 1999 and headquartered in San Diego, Dexcom is a public company traded on NASDAQ (DXCM).