Work Flexibility: Onsite

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 devicesUtilize strong understanding of process capability analysis (Cp, Cpk, Pp, Ppk), statistical process control (SPC), and other statistical tools (DOE, ANOVA) to ensure process repeatability and scalabilityLead IQ/OQ/PQ validations for critical processes such as:Injection MoldingBonding 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 experience

Preferred 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.

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.