Sr Staff QA Engineer
Core
Subject matter expert for material characterization, formulation science, and risk management in continuous glucose monitoring (CGM) devices.
Role type
Sr Staff Design Quality Engineer (Materials Science)
Builds
CGM sensors and biosensing technology
Domain
Medical devices / Continuous Glucose Monitoring / Biosensing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
material characterization, formulation development, analytical chemistry, ISO 14971 risk management, Design Controls, regulatory submissions, statistical data interpretation
Preferred skills
advanced degree (MS or PhD), experience with polymers, enzymes, sensor chemistries, adhesives, coatings
Technologies
ISO 14971, Design Controls, SDLC, Design Transfer
Responsibilities
Lead quality oversight of characterization and qualification strategies for raw materials and formulations; establish traceability between material attributes and device safety; partner with R&D and Manufacturing teams; drive risk-based decision making; provide Design Quality leadership for verification activities; represent Design Quality in audits and regulatory submissions
Seniority
Sr Staff, hands-on IC with strategic leadership