Jobs via Dice
Inari Medical Staff R&D Process Development Engineer
Jobs via Dice, Irvine, California, United States, 92713
Overview
Staff R&D Process Development Engineer role at
Jobs via Dice . Fully onsite in Irvine, CA with in-office requirement 5 days a week. 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. 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 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 :
Bachelor's degree in Engineering (Mechanical or Biomedical preferred)
4+ years of work experience
Preferred Qualifications :
Subject Matter Expertise in design for injection molded parts and molding process development
Experience in process development/manufacturing engineering within medical device space 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
Salary: $100,700 - $165,100 plus bonus eligible + benefits. Individual pay is based on skills and experience. 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. Note: This job listing contains content including compensation ranges and general opportunities; it does not guarantee current or future openings.
#J-18808-Ljbffr
Staff R&D Process Development Engineer role at
Jobs via Dice . Fully onsite in Irvine, CA with in-office requirement 5 days a week. 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. 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 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 :
Bachelor's degree in Engineering (Mechanical or Biomedical preferred)
4+ years of work experience
Preferred Qualifications :
Subject Matter Expertise in design for injection molded parts and molding process development
Experience in process development/manufacturing engineering within medical device space 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
Salary: $100,700 - $165,100 plus bonus eligible + benefits. Individual pay is based on skills and experience. 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. Note: This job listing contains content including compensation ranges and general opportunities; it does not guarantee current or future openings.
#J-18808-Ljbffr