We are seeking a talented Process Development Engineer to support the development and commercialization of our next generation thrombectomy system. This engineer will play a critical role in developing and validating manufacturing processes that enable reliable production of highly complex interventional devices, with strong collaboration with R&D engineering.
This role is fully onsite role in Irvine, CA with the expectation to be in office 5 days a week.
Check out our product portfolio : Stryker Inari
What you will do :
- Develop, optimize, and validate manufacturing processes for next generation thrombectomy devices (capital and disposables)
- Develop fixtures and equipment for precision assembly and testing of medical devices
- Utilize strong understanding ofprocess capability analysis (Cp, Cpk, Pp, Ppk), statistical process control (SPC), and other statistical tools (DOE, ANOVA) to ensure process repeatability and scalability
- Lead IQ / OQ / PQ validations for critical processes such as :
Injection Molding
Bonding processes (e.g., automated gluing, ultrasonic welding, etc.)In-process inspections and testing (e.g., leak testing)Collaborate with R&D to translate design intent into robust, commercially scalable processes including the use of DFM best practicesSupport design transfer activities from the R&D environment to a cleanroom environmentSupport root cause investigations and implement CAPAs for process-related issuesDocument processes, validations, and risk assessments in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 25539 (vascular implants)What you need :
Required Qualifications :
Bachelor's degree in Engineering (Mechanical or Biomedical preferred)4+ years of work experiencePreferred Qualifications :
Subject Matter Expertise level of understanding pertaining to the design for injection molded parts and molding process developmentExperience in process development / manufacturing engineering within medical device space specifically for injection molded componentsProficiency in fixture / tooling design using SolidWorks CADSkilled in statistical analysis and software (Minitab, JMP)Familiarity with risk management (DFMEA, PFMEA) and regulatory expectations for Class II / III interventional devicesSix Sigma Green / Black Belt certification$100,700 - $165,100 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
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