Scientist LC/GC Data Interpretation, Medical Device
Core
Interpret LCMS and GCMS data to identify extractables from medical devices for FDA regulatory approval and safety assessment.
Role type
Scientist LC/GC Data Interpretation
Builds
Chemical characterization data for medical device regulatory submissions
Domain
Medical device regulatory testing / Analytical chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LCMS data interpretation, GCMS data interpretation, unknown compound identification, high-resolution data analysis, method development, method validation, ISO 10993-18 familiarity
Preferred skills
Thermo LCMS experience, Agilent GCMS experience, Compound Discoverer, Unknown Analysis software
Technologies
Compound Discoverer, Trace Finder, Unknowns Analysis, Mass Hunter
Responsibilities
Identify peaks in LCMS/GCMS extracts above reporting limits, assess extractables for safety/risk context, operate lab equipment for extended periods, maintain focus on high-throughput workflows
Seniority
Mid-level Scientist (3+ years industry experience with MS or 2+ years with PhD)