Sr Design Assurance Engineer

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**Senior Design Assurance Engineer**
**21000NDW**
**Santa Ana, CA**
**Careers That Change Lives**
In this exciting role as a **Senior Design Assurance Engineer** you will have the opportunity to work within the quality function within the Transcatheter Mitral Valve Replacement (TMVR) business in Santa Ana, CA. We are pioneering the first transcatheter mitral valve solution for Medtronic and this exciting new aspect of the Structural Heart business is focused on clinically viable solutions that improve efficiency of procedures and deliver successful patient outcomes.
Medtronic is intensely focused on creating a workplace environment which reflects our standing as the worlds top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business.
Do meaningful work, make a difference, and improve lives starting with your own. Come for a job, stay for a career.
**Structural Heart and Aortic**
The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valvesaortic, pulmonic, mitral, tricuspidand the placement of stent grafts to treat aneurysms and dissections of the bodys largest artery, the aorta.
Responsibilities include the following but not limited to:
Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
Completes risk analysis studies of new design and processes.
Develops, coordinates and analyzes design verification studies for products.
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
Ensures that corrective measures meet acceptable reliability standards.
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
Conducts gap assessments on risk management documentation to the requirements of ISO 14971 and new Medical Device Regulations (MDR).
**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 4 years of experience in Quality and/or Engineering or Advanced degree in Engineering, Science or technical field with 2 years of experience in Quality and/or Engineering.
**Nice to Have**
Medical device industry experience
Quality Engineering experience
ASQ-CQE, CQA, CBA or equivalent certifications
Strong analytical skills
Excellent communication skills
Ability to work effectively within team and across function
**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.
Categories
Healthcare
Engineering
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CRM_ Clinical Specialist_ Central
Medtronic
台中市, 407 TW
Next Job:
Senior Product Engineer - AME
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North Haven, CT 06473 US
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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