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

Medtronic•Irvine, CA

3d•$107,200 - $160,800•Onsite

About The Position

Medtronic Neuroscience is focused on transforming care for patients with neurological, spinal, and chronic pain conditions. Through meaningful innovation and strong clinical partnerships, we help clinicians deliver therapies that improve lives and expand what is possible in-patient care. Neurovascular is focused on improving outcomes for patients affected by stroke and cerebrovascular disease. We develop innovative technologies that support fast, precise treatment and help clinicians make a meaningful difference in critical moments. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. As a Neurovascular Senior Design Quality Engineer, you will partner directly with product development teams to influence the design, reliability, manufacturability, and quality of neurovascular medical devices. This role provides technical quality leadership throughout new product development, applying risk management, data analysis, and design quality principles to support safe, effective, and reliable products.

Requirements

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.
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.
The employee is regularly required to be independently mobile.
The employee is also required to interact with a computer, and communicate with peers and co-workers.
Candidates below the Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

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.

Responsibilities

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.