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Design Quality Engineering Manager

Company: Medtronic
Location: irvine
Posted on: May 3, 2021

Job Description:

Careers That Change Lives What does it take to be a leader at Medtronic? We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes. In this exciting role as a Design Quality Engineering Manager you will have design assurance responsibility for Neurovascular Hemorrhagic and Ischemic Stroke products. Lead design assurance engineers as they work with the cross-functional team to develop new products and ensure high levels of performance, reliability, safety, manufacturing capability and quality. Apply your knowledge of engineering, design control principals, quality engineering, risk, and communication skills to positively influence product design, achieve high customer satisfaction and improve patient outcomes. A Day in the Life Responsibilities may include the following and other duties may be assigned. Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems. May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, machines, processes or products. Directs the development of new concepts from initial design to market release. Manages feasibility studies of the design to determine if capable of functioning as intended. Monitors documentation maintenance throughout all phases of research and development. Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Assist quality management in setting the strategy for the Design Quality Organization. Devise and execute processes to ensure appropriate escalation of quality issues. Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations. Provide guidance to Quality Engineering staff and other personnel and ensures that design control requirements are being met in an effective manner. Establish and maintain system for measurement and reporting of quality results. Participates and interfaces with regulators during regulatory inspections. Promotes continuous improvement in design control activities and use of quality tools with design team. Lead or participate in design reviews to evaluate designs and to help identify alternative design solutions. Must Have: Minimum Requirements Bachelor's Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience in Engineering, Quality, and/or experience in a regulated industry. Nice to Have Experience in vascular devices such as. embolic coils, stents, catheters, balloons, aspiration devices, and/or guide wires. Certifications including but not limited to: Quality Engineer, Manager of Quality and Operational Excellence, Biomedical Auditor, and/or Six Sigma Black Belt from ASQ or other equivalent. About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description 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. For Office Roles: While performing the duties of this job, 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)Additional Information Posting Date: Feb 8, 2021 Travel: Yes,

Keywords: Medtronic, Irvine , Design Quality Engineering Manager, Other , irvine, California

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