Product Operations and Support Specialist
Core
Tier 2 escalation point for an integrated hardware-software medical device used in live clinical environments, handling technical troubleshooting, complaint handling, and product operations.
Role type
Senior IC Product Operations and Support Specialist
Builds
Integrated hardware-software medical devices for clinical screening and care
Domain
Healthcare / Medical Devices / AI
Required skills
Hardware-software troubleshooting, Medical device complaint handling, Quality management systems (QMS), Regulatory standards knowledge (FDA 21 CFR 820/QMSR, ISO 13485, EU MDR), Knowledge base creation, Cross-functional project coordination, Remote work autonomy
Preferred skills
Imaging medical devices, Telemedicine, EHR integrations, Primary care/point-of-care environments
Technologies
EHR systems, Medical imaging hardware, Clinical workflow software
Responsibilities
Serve as Tier 2 escalation point for customer feedback and semi-technical issues; Troubleshoot problems spanning hardware-software boundaries; Reproduce and investigate issues at remote customer sites; Capture and route device complaints per regulatory requirements; Identify reportable complaints or adverse events; Develop knowledge base articles and troubleshooting guides; Own product operations initiatives and internal tooling requirements; Coordinate cross-functional projects from intake to delivery; Translate customer issues into product improvement recommendations.
Seniority
Senior, hands-on IC with ownership