Sr Process Engineer
Core
Develop, validate, and implement mechanical and analytical test methods for material characterization and process monitoring in medical device manufacturing.
Role type
Senior Process Development Engineer
Builds
Test capabilities for material characterization, process monitoring, and commercial manufacturing support
Domain
Medical devices / Continuous Glucose Monitoring (CGM) / Biosensing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development, manufacturing processes, test method development, engineering experimentation, problem solving, DOE, statistical analysis, root cause analysis, technical documentation, risk documentation (pFMEAs)
Preferred skills
JMP, Minitab, Python, Excel, FDA 21 CFR 820, ISO 13485
Technologies
JMP, Minitab, Python, Excel
Responsibilities
Support process and test method development for materials and products; Define process/test requirements based on design inputs and material properties; Plan, execute, and document experiments to characterize new processes; Compile, trend, and evaluate test data to define process limits; Partner with Manufacturing, Quality, and Automation teams to troubleshoot and implement new processes; Prepare technical documentation including protocols, reports, and risk inputs; Participate in design reviews, failure investigations, and continuous improvement activities
Seniority
Senior, hands-on IC