Lead Digital Health Quality Engineer
Core
Lead quality engineering for Software as a Medical Device (SaMD) and digital health products, ensuring compliance with medical device regulations and managing design controls throughout the software lifecycle.
Role type
Lead Digital Health Quality Engineer (Software Validation & Regulatory Compliance)
Builds
SaMD and Digital Health software products compliant with global regulations
Domain
Digital Health / Medical Devices / Software Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control management, Risk management (ISO 14971), Software validation (GAMP5, CSA), Regulatory documentation (QMS, DHF), Root cause analysis, Audit support, Cybersecurity quality activities, Technical writing
Preferred skills
Medical device cybersecurity, AI/ML, Connected devices, Digital Health emerging technologies
Technologies
ISO 14971, IEC 62304, 21 CFR 820.30, EU MDR, GAMP5, CSA
Responsibilities
Author and approve QMS and project documentation for SaMD development; Perform design control and risk management activities including cybersecurity; Support regulatory submission documentation and agency audits; Lead continuous improvement initiatives for Design History File and Risk Management; Communicate project quality status and recommend actions to resolve issues
Seniority
Senior, hands-on IC with strategic oversight
