Process Engineer

Enovis•Vista, CA

45d•Onsite

About The Position

Enovis Corporation is seeking an experienced Process Engineer to join their Manufacturing Engineering team. This role is integral to driving the medical technology industry forward by transforming patient care and creating better patient outcomes. The Process Engineer will specialize in the development and optimization of formulations, manufacturing processes, and equipment systems from pilot through full-scale production. This individual will lead cross-functional process improvement initiatives, evaluate technical data to establish specifications, and drive the implementation of innovative technologies and automation solutions. The role requires independent management of complex projects and priorities with minimal supervision.

Requirements

BA/BS in Mechanical Engineering or relevant field of study
Minimum 5 years of experience with CAD modeling (Solidworks)
Minimum 5 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

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
Defines equipment needs for the process and builds objective cases for investment
Leads planning and implementation of NPI projects
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