Manufacturing Engineer

This role is for a Sr. Manufacturing Engineer supporting medical device manufacturing in Irvine, CA.
The candidate will focus on equipment/process validation and manufacturing process improvements.
Strong project management and Lean Six Sigma experience are important.
Requires 4+ years of relevant experience, preferably in a medical device manufacturing environment.

Develop, improve, and optimize manufacturing processes, equipment, tooling, and production layouts.
Lead equipment qualification and process validation activities.
Manage engineering projects, including timelines, budgets, resources, and implementation.
Identify and resolve manufacturing issues to improve quality, efficiency, and production yield.
Support Lean Six Sigma and continuous improvement initiatives.
Work with Design, Quality, and Operations teams to ensure products are manufacturable and meet requirements.
Ensure manufacturing processes comply with medical device regulations and quality standards.
Evaluate equipment and processes and recommend modifications and improvements.