Senior Design Quality Engineer - Neurovascular - Irvine, CA (Onsite).

Careers That Change Lives

As a Neurovascular Sr. Design Quality Engineer, you will have responsibility for directly contributing to the design of life-saving Neurovascular devices.

You will integrate into every aspect of new product development, processes, and planning to deliver world-class and high-quality treatments.

Problems and issues faced are difficult, complex, often undefined, and require detailed information gathering, analysis and investigation.

Critical thinking and curiosity are vital to finding timely solutions to ensure optimal performance and safety.

As a voice of the patient, Design Quality Engineers at Medtronic go well beyond the basic requirements of meeting internal and external requirements;

they heavily incorporate into the design team and personally contribute to the technical design and performance.

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day.

It’s no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

To learn more about Inclusion & Diversity at Medtronic

Neurovascular OU :

The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care.

Location : Irvine, CA

Ability to travel up to :

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Direct contribution and hands-on collaboration with R&D and Process Development to influence and contribute to the design of cutting-edge medical devices.
• Flexes with other Quality Engineers to provide targeted support depending on project phase.
• Mentor other engineers and be mentored.
• Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
• Apply Design for Manufacturability and Reliability principles.
• Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
• Identifies and manages risk throughout the product lifecycle with the application of risk management tools.
• Completes risk analysis studies of new design and processes.
• Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
• Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
• As necessary, proposes changes in design or formulation to improve system and / or process reliability.
• May serve is Core Reliability and Quality Engineer for R&D Programs
• Oversees Validation & Verification activities.

Must Have (Minimum Requirements)

• Bachelor’s degree (Engineering or Science) required with a minimum of 4 years of experience in Engineering and / or Quality.
• OR advanced degree with a minimum of 2 years of Engineering and / or Quality.

Nice to Have ( Preferred Qualifications )

• Experience with Vascular / Neurovascular devices is highly preferred.
• Background in product realization and Design Engineering / Quality
• Advanced Statistics 2+ years working with Minitab, DOE, Capability analysis, stability analysis, graphical analysis, etc.
• Experience with Risk Management, Analysis and Problem Solving Techniques
• Process Improvement Methodologies, such as Six sigma, DOE, LEAN
• ISO standards including ISO13485 Medical Device Directives (MDD) / Vigilance Reporting, EU MDD, EU MDR, FDA QSR
• Demonstrated proficiency in decision making preferably across a broad spectrum of Quality Engineering responsibilities.
• Project management methods and tools
• Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• ASQ Certification

A preferred candidate has practical expertise in one (or more) of these key topics :

• DRM Requirements Flow-down, Design Characterization, & Process Characterization
• Material Engineering / Testing Metals
• Material Engineering / testing Polymers
• Reliability and Risk Management
• Advanced Statistics
30+ days ago