Process Development Engineer

Stryker · Irvine, CA

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CMCFull-time$103k–$171kCompany career page

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What they're looking for

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

What you'll be doing

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

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Date posted4 days ago

Last source check1 day ago

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