Process Engineer

Enovis•Vista, CA

15d•Onsite

About The Position

The process engineer is responsible for developing and optimizing formulations, manufacturing processes, and equipment requirements from pilot to full-scale production. Collaborates cross-functionally to ensure process compatibility, evaluates test data to establish specifications, and supports implementation of new technologies and process improvements while resolving moderately complex technical issues.

Requirements

BA/BS in Mechanical Engineering or relevant field of study
Minimum 2 years of experience with CAD modeling (Solidworks)
Minimum 2 years of experience with GMP and QMS documentation

Nice To Haves

Very hands on engineer
Knowledgeable with SPC
Knowledgeable with FDA regulation (21 CFR 820) and ISO 13485
Experience with IQ/OQ/PQ
Knowledge and experience with GMP and QMS documentation

Responsibilities

Works on, and leads projects related to process improvement
Keeps track of relevant KPI’s to determine improvement opportunities
Analyzes data to determine trends on process quality and output
Makes use of root cause analysis tools to review and resolve process issues
Implementation of EGX manufacturing tools and principles.
Manufacturing process design and validation
Creates and keeps manufacturing documentation current
Ensures that manufacturing metrics are accurate based on time and process studies
Interacts frequently with functional peer professionals in Operations, Quality, Supply Chain, Warehouse, Maintenance, Customer Care and Human Resources