Senior Design Quality Engineer

Job 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)
• 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

• 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
• Unrestricted U.S. work authorization at the time of hire and for the duration of employment; U.S. work authorization sponsorship is not offered below Principal level
• For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
• Experience with vascular or neurovascular medical devices
• Experience in product realization, design engineering, and/or design quality engineering
• Advanced statistical analysis, including Minitab, Design of Experiments (DOE), capability analysis, stability analysis, and graphical analysis
• Knowledge of medical device quality systems and regulations, including ISO 13485, EU MDR, and FDA QSR
• Practical expertise in requirements flow-down and design characterization, metals material engineering and testing, or polymer material engineering and testing

Demonstrates expertise in quality engineering, statistical analysis, and risk management within regulated environments, particularly in the development and commercialization of vascular or neurovascular medical devices. Proven ability to lead cross-functional teams and mentor engineers to enhance product reliability and quality.

• Quality Engineering Leadership
• Statistical Analysis
• Risk Management Methodologies
• Design of Experiments (DOE)
• Medical Device Quality Systems

• Statistical Analysis
• Design of Experiments (DOE)
• Risk Management
• Quality Engineering
• Product Development
• Design Quality Engineering
• Process Controls
• Reliability Studies
• Data-Driven Problem Solving
• Requirements Flow-Down

• Mentoring
• Collaboration
• Decision Making

• ISO 13485
• EU MDR
• FDA QSR
• Vascular Medical Devices
• Neurovascular Medical Devices

• Minitab
• Graphical Analysis
• Capability Analysis
• Stability Analysis