17 days ago
Base Salary
$96k - $160k/yr
Responsibilities
- Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering teams to investigate, document, and resolve software- and device-related postmarket issues.
- Develop and continuously improve complaint investigation processes aligned with software risk management activities, including hazard analysis, DFMEA, PFMEA, and product risk assessments.
- Evaluate product performance, investigate anomalies, conduct engineering studies, and identify root causes using structured problem-solving, statistical analysis, and industry-standard tools.
- Analyze and communicate investigation outcomes to technical and non-technical stakeholders, providing recommendations for decision-making.
- 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.
- Partner with product development and quality teams to convert postmarket insights into product, user-experience, 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 activities across requirements, architecture, design, development, verification, validation, release, and postmarket surveillance.
- Strong understanding of software risk management principles and risk-based decision-making.
- Working knowledge of cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications.
- Ability to investigate complex issues, determine root causes, interpret data and trends, and drive corrective actions.
- Strong communication and collaboration skills, including the ability to explain complex technical concepts to technical and non-technical stakeholders.
- Ability to balance technical depth with business impact, product quality, patient safety, compliance, and customer experience.
Benefits
- Comprehensive benefits program.
- Global growth opportunities and access to in-house learning programs and/or qualified tuition reimbursement.
- Home-office-based flex workplace with no assigned workstation; office visits are determined with the manager.
- Candidates must live within commuting distance of their assigned Dexcom site, typically 75 miles/120 km.
- 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.