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1+ months

Principal Design Quality Engineer

Irvine, CA 92604
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Principal Design Quality Engineer


Irvine, California, United States

Requisition #:


Post Date:

Jan 04, 2022

**Careers That Change Lives**

In this exciting role as a **PrincipalDesign QualityEngineer** you will haveresponsibility forsupporting new product development for the Neurovascular business within theRestorativeTherapies Group. As a member of the Design Assurance Engineering team, you will have primary responsibility for influencing product quality and reliability outcomes across new product development projects.

TheRestorative Therapies Groupdevelops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

The Specialty Therapiesdivision of RTG offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear,nose, and throat, as well as stroke products.

A Day inthe Life

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

+ Actively represent Quality Engineering function as Quality Core Team Member (QCTM) on product development teams

+ Mentor less senior Quality Engineers and technicians

+ Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including those for Voice of the Customer, establishing design inputs/outputs, Design Verification Validation, Process Characterization Validation, Component Qualification and Risk Management.

+ Hands on participantin early stages of product development including but not limited to physician interaction component engineering, competitive product and prototype testing.

+ Identifies quality characteristics and validation criteria for components, subassemblies and finished devices.

+ Ensures product development activities are conducted in accordance with FDA, QSR, ISO 13485 and internal Quality System requirements.

+ Drive predictive engineering methodology principles (DRM) incorporating reliability and capability analysis assessments in Design and Manufacturing processes.

+ Completes risk analysis studies of new design and processes.

+ Ensures that corrective measures meet acceptable reliability standards.

+ As necessary, proposes changes in design or formulation to improve system and/or process reliability.

+ Travel requirement:less than 25%

**Must Have: Minimum Requirements**

**To be considered for this role, please ensure the minimum requirements are evident on your resume.**

Bachelors Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.

**Nice to Have**

+ Experience with vascular devices, embolic coils, stents and/or catheters

+ Design, Reliability and Manufacturability (DRM) and/or Design for Six Sigma (DFSS)

+ Experience with Risk Management

+ Self-motivated, driven and committed to a team approach

+ Strong interpersonal, organizational and project management skills

+ Strong oral, presentation and technical writing skills

**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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2022-03-08 Expires: 2022-06-06
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Principal Design Quality Engineer

Irvine, CA 92604

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