Senior Design Quality Engineer - Irvine

Medtronic•Irvine, CA

3d•Onsite

About The Position

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Neurovascular operating unit advances treatment of stroke, brain aneurysms, and vascular disorders through innovative endovascular technologies. With devices designed for revascularization, embolization, and precise intervention, we support clinicians in delivering timely, effective care for complex neurovascular conditions. 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 meeting internal and external requirements; they actively integrate into the design team and personally contribute to the technical design and performance. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

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

Nice To Haves

Experience with Vascular/Neurovascular devices
Background in product realization and Design Engineering / Quality
Advanced Statistics – 2+ years working with Minitab, DOE, Capability analysis, stability analysis, graphical analysis, etc.
Risk Management and Analysis
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
Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
ASQ Certification
DRM – Requirements Flow-down, Design Characterization, & Process Characterization
Material Engineering / Testing – Metals
Material Engineering/testing – Polymers

Responsibilities

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 designs 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 as Core Reliability and Quality Engineer for R&D Programs.
Oversees Validation & Verification activities.