Hardware Engineer 2
Core
Investigate postmarket issues, analyze hardware anomalies, and drive corrective actions to ensure patient safety and regulatory compliance for continuous glucose monitoring devices.
Role type
Senior hardware quality engineer (postmarket investigations)
Builds
Postmarket quality processes, CAPA, and risk mitigation strategies for CGM devices
Domain
Medical devices / Consumer health technology / Biosensing
Required skills
hardware risk management, failure analysis, statistical analysis, regulatory compliance (FDA/ISO), CAPA management, root cause analysis, electromechanical systems knowledge, reliability engineering, hazard analysis
Preferred skills
medical device lifecycle experience, signal detection, clinical impact assessment, cross-functional collaboration
Technologies
DFMEA, PFMEA, ISO 13485, ISO 14971, FDA 21 CFR Part 820, EU MDR
Responsibilities
Investigate software- and device-related postmarket issues, develop complaint investigation processes, evaluate product performance anomalies, conduct hardware-focused risk assessments, communicate investigation outcomes to stakeholders, support CAPA and Health Hazard Evaluations, partner with R&D to translate insights into product improvements
Seniority
Mid-Senior, hands-on IC
