• Senior R&D Process Engineer

    Stryker (Irvine, CA)


    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 (https://www.inarimedical.com/)

     

    Clot Triever portfolio: Clot Triever (https://www.inarimedical.com/clottriever-system)

    What you will do:

    + 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).

    What you need:

    Required Qualifications:

    + Bachelor's degree in Engineering (Mechanical or Biomedical preferred)

    + 2+ years of work experience

    Preferred Qualifications:

    + Experience in process development/manufacturing engineering within interventional cardiology, peripheral vascular, or neurovascular devices.

    + Prior exposure to nitinol stents, catheter delivery systems, or thrombectomy devices is highly preferred.

    + Deep understanding of endovascular catheter systems, stents, and retrieval devices.

    + Experience with nitinol processing (crimping, heat setting, shape memory characterization).

    + Proficiency in fixture/tooling design (SolidWorks, CAD) for catheter & stent integration.

    + Skilled in statistical analysis and software (Minitab, JMP).

    + Familiarity with risk management (DFMEA, PFMEA) and regulatory expectations for Class II/III interventional devices.

    + Hands-on experience with laser welding, thermal bonding, hydrophilic coatings, and catheter extrusion processes.

    + Strong communication and documentation skills to interface with R&D, Manufacturing, and Quality teams.

    + Six Sigma Green/Black Belt certification

     

    $88,800 - $142,300 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

     

    Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

     

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.