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

About the role

Provide design quality engineering leadership for neurovascular medical devices, ensuring compliance and reliability.

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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.
• Experience with FDA 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.

Physical Job Requirements

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Benefits

• Employee Stock Purchase Plan
• Tuition reimbursement
• 401(k) plan plus employer contribution and match

Pay

$107k – $161k

Schedule

On-site, 4 days per week