Process Development Engineer

$102.7k - $171.1k

Stryker

Irvine, CA

Responsibilities

Lead manufacturing process development at external suppliers through product introduction lifecycle
Design and execute process characterization studies, DOE, and statistical analyses for process capability
Develop and coordinate manufacturing industrialization plans including validation and readiness reviews
Drive supplier technical execution through reviews, deliverable monitoring, and issue resolution
Create and maintain validation documentation including protocols, reports, specifications, and work instructions

Requirements

Bachelor's degree in Mechanical, Biomedical, or Manufacturing Engineering
Minimum 5 years medical device industry engineering experience
Experience developing manufacturing processes for new products
Direct experience working with external suppliers or contract manufacturers
Proficiency in process characterization, DOE, statistical analysis, and IQ/OQ/PQ validation
Preferred: catheter, minimally invasive, or electromechanical device background
Preferred: familiarity with extrusion, laser, thermal bonding, injection molding, or automated assembly

Compensation: $102,700 - $171,100 USD annual

Apply

Vacancy posted 22 days ago

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