Stryker Employment Company, LLC
Staff R&D Process Development Engineer
Stryker Employment Company, LLC, Irvine, California, United States, 92713
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 :
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 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 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.
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.
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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 :
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 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 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.
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.
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