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# Senior Design Quality Engineer, Irvine California (On-Site)

- **Company:** Medtronic Inc.
- **Location:** Irvine, CA, United States
- **Experience:** Expert
- **Salary:** $107,200.0 - $160,800.0
- **Contract:** Temporary contract
- **Skills:** Minitab, Data Analytics
- **Published:** August 30, 2026
- **Apply:** https://dejobs.org/x/x/5B6ACB2945BE4198B6FBD6BAF46BD467/job/

## About the Role

* Bachelor's degree in Engineering or Science and a minimum of 4 years of engineering and/or quality experience, or an advanced degree with a minimum of 2 years of engineering and/or quality experience.
 * Experience supporting product development, design quality, quality engineering, or related engineering activities.
 * Experience applying statistical analysis and data-driven problem-solving techniques to engineering or quality challenges.
 * Experience working in a regulated environment and supporting design control, risk management, verification, or validation activities., * Experience with vascular or neurovascular medical devices.
 * Experience in product realization, design engineering, and/or design quality engineering.
 * Advanced statistical analysis experience, including Minitab, Design of Experiments (DOE), capability analysis, stability analysis, and graphical analysis.
 * Knowledge of medical device quality systems and regulations, including ISO 13485, European Union Medical Device Regulation (EU MDR), and U.S. Food and Drug Administration Quality System Regulation (FDA QSR).
 * Practical expertise in one or more of the following areas: requirements flow-down and design characterization, metals material engineering and testing, or polymer material engineering and testing.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

## Description

* Partner with R&D and Process Development teams to influence product design decisions throughout the development lifecycle.
 * Lead and support reliability studies, design characterization activities, and design of experiments (DOE) to evaluate product and process performance.
 * Apply risk management methodologies to identify, assess, and mitigate product and process risks from development through commercialization.
 * Develop and recommend test methods, statistical approaches, and process controls to achieve reliability and quality objectives.
 * Analyze product performance data, process metrics, and investigation results to identify improvement opportunities and support decision making.
 * Provide quality engineering leadership for verification, validation, and design transfer activities.
 * Recommend design, material, or process improvements to enhance product performance, manufacturability, and reliability.
 * Mentor engineers and collaborate across functions to support project execution and organizational capability development.


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