Work Flexibility: Onsite
We are seeking a talented Process Development Engineer to support the development and commercialization of our next-generation endovascular thrombectomy system, combining a retrievable nitinol stent with a catheter-based delivery and retrieval platform. This engineer will play a critical role in developing and validating manufacturing processes that enable reliable production of highly complex interventional devices.
This role is hybrid in Irvine, CA with the expectation to be in office 5 days a week.
Check out our product portfolio: Stryker Inari
Clot Triever portfolio: Clot Triever

• Develop, optimize, and validate processes for nitinol-based implantable components (stent crimping, heat setting, shape recovery, electropolishing).
• Design and qualify custom fixtures and tooling for catheter assembly, nitinol handling, and retrieval system integration.
• Conduct process capability studies (Cp, Cpk, Pp, Ppk) and apply statistical tools (DOE, SPC, ANOVA) to ensure repeatability and scalability.
• Lead IQ/OQ/PQ validations for critical processes such as:
• Laser welding (catheter to nitinol frame interfaces).
• Thermal bonding / adhesive bonding of catheter subassemblies.
• Braiding, coiling, and shaft assembly for deliverability and torque response.
• Crimping and deployment system verification.
• Collaborate with R&D to translate design intent into robust, commercially scalable processes.
• Support root cause investigations and implement CAPAs for process-related issues.
• Document processes, validations, and risk assessments in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 25539 (vascular implants).