2 hours ago
Base Salary
$96k - $160k/yr
Responsibilities
- Investigate, document, and resolve software- and device-related postmarket issues with cross-functional partners.
- 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 problem-solving 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 improvements to product performance, user experience, and patient safety.
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 throughout 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, data analysis, trend identification, and root-cause investigation.
- Working knowledge of cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications.
- Strong communication and collaboration skills, including the ability to explain complex technical concepts to varied stakeholders.
- Ability to balance technical depth with business impact, product quality, patient safety, compliance, and customer experience.
Benefits
- Full and comprehensive benefits program.
- Global growth opportunities and access to in-house learning programs and qualified tuition reimbursement.
- Opportunity to work on life-changing continuous glucose monitoring technology.
- Travel required: 0–5%.
Categories
About Dexcom
Empowering People to Take Control of Health Dexcom Corporation (NASDAQ DXCM) has been a pioneer in glucose sensing for more than 25 years. Since 1999, we have developed innovative technologies that transformed how people manage diabetes. Our products are part of people’s daily lives, empowering them to live confidently and feel more in control, free to pursue their dreams. Headquartered in San Diego, California, with operations around the world, Dexcom leads by listening to the needs of users, caregivers, and providers, to simplify and improve glucose management.