Senior Scientist 1
Core
Technical subject matter expert responsible for biological safety evaluation of medical devices, materials, and manufacturing processes throughout the product lifecycle.
Role type
Senior Scientist I, Biocompatibility
Builds
Glucose monitoring systems (FreeStyle Libre) and biosensors for home and hospital use
Domain
Medical Devices / Biocompatibility / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 10993 series expertise, toxicological risk assessment, biological evaluation reporting, GLP testing oversight, material characterization, extractables & leachables analysis, regulatory submission support
Preferred skills
Board-certified toxicologist (DABT), FDA interaction experience, chemical characterization knowledge
Technologies
MS Office, SharePoint, OneDrive
Responsibilities
Lead biological safety assessments for Class I–III medical devices; Author and approve Biological Evaluation Plans (BEPs) and Reports (BERs); Design and oversee biocompatibility studies (in vitro/in vivo) with external labs; Mentor junior scientists and drive best practices; Interpret toxicology and chemistry characterization data; Monitor global regulatory trends and update internal procedures
Seniority
Senior, hands-on IC with strategic project leadership
