Process Development Engineer 1
Core
Develop and implement manufacturing and test processes for continuous glucose monitoring (CGM) devices, supporting process characterization, experimentation, and troubleshooting.
Role type
Junior IC process development engineer (medical devices)
Builds
CGM devices and their manufacturing/test processes
Domain
Medical device manufacturing / Biosensing technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process formulation, test method development, engineering experimentation, data analysis, Design of Experiments (DOE), statistical analysis, root cause analysis, technical documentation, risk documentation (pFMEAs)
Preferred skills
FDA-regulated environment familiarity, ISO 13485 knowledge, medical device manufacturing experience
Technologies
JMP, Minitab, Python, Excel
Responsibilities
Plan and execute experiments to characterize new processes; compile and trend test data to identify process variables; collaborate with cross-functional teams to troubleshoot and implement processes; prepare protocols, reports, and risk documentation; participate in design reviews and failure investigations.
Seniority
Entry-level, hands-on IC