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

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 of process 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.

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.