Principal Process Development Engineer - Data Analytics
Core
Technical authority for advanced data analysis supporting engineering, manufacturing, and quality initiatives in high-volume medical device programs.
Role type
Principal Process Development Engineer (Data Analytics)
Builds
Robust protocols, final reports, and data-driven paths for product lifecycle from development to commercialization.
Domain
Medical device manufacturing / Regulatory compliance (FDA, ISO 13485, GMP)
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Advanced statistical methods (DOE, regression, ANOVA, multivariate), Python, R, SQL, JMP, Minitab, Six Sigma Blackbelt, Risk management (FMEA, SHA), Process validation (IQ/OQ/PQ), Machine learning
Preferred skills
Cross-functional influence, Mentoring statistical thinking, Technology transfer expertise
Technologies
Python, R, SQL, JMP, Minitab
Responsibilities
Design and interpret complex Designs of Experiments (DOEs), Lead data-driven root cause investigations, Mentor engineers on statistical thinking, Support technology transfer programs, Analyze large complex datasets for decision-making
Seniority
Principal, hands-on IC with mentorship