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Staff R&D Process Development Engineer
Staff R&D Process Development EngineerStryker Group • Irvine, CA, US
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Staff R&D Process Development Engineer

Staff R&D Process Development Engineer

Stryker Group • Irvine, CA, US
6 days ago
Job type
  • Full-time
Job description

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 practices
  • Support design transfer activities from the R&D environment to a cleanroom environment
  • 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)
  • What you need :

    Required Qualifications :

  • Bachelor's degree in Engineering (Mechanical or Biomedical preferred)
  • 4+ years of work experience
  • Preferred Qualifications :

  • Subject Matter Expertise level of understanding pertaining to the design for injection molded parts and molding process development
  • Experience in process development / manufacturing engineering within medical device space specifically for injection molded components
  • Proficiency in fixture / tooling design using SolidWorks CAD
  • Skilled in statistical analysis and software (Minitab, JMP)
  • Familiarity with risk management (DFMEA, PFMEA) and regulatory expectations for Class II / III interventional devices
  • Six 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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