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12 days old

Principal R-D Engineer

Irvine, CA 92604
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Principal R-D Engineer


Irvine, California, United States

Requisition #:


Post Date:

Jan 06, 2021

**Careers That Change Lives**

In this exciting role, as a Principal Engineer in the Released Product Engineering (RPE) group you will provide engineering support for technologies used to treat brain aneurysms, arteriovenous malformations and other vascular lesions. The Neurovascular Business is one of the fastest growing businesses and helps patients all over the globe. This support will lead to the introduction of new products in key markets around the world, education of products to our customers and post commercialization engineering studies. This role reports to the RD engineering manager in RPE group. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.

**A Day in the Life**

+ Work cross functionally with Manufacturing, Quality, Regulatory, Marketing and Clinical

+ Utilize a high level of self-motivation and hands-on skills to simplify complicated problems. Assignments are often self-initiated; determines and pursues courses of action necessary to obtain desired results

+ Provide technical input supporting submissions to regulatory bodies and governmental agencies

+ Design, develop and validate test methods to support additional studies post-commercialization

+ Remediate design history and product specification

+ Apply engineering principles to product design analysis and assessment

+ Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions

+ Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures

+ Prepare technical documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc.

+ Coordinate and lead competitive testing and aging testing

+ Interact with physicians to assist with product demonstrations

+ Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment

+ Provide guidance to technicians and pilot associates, complying with applicable FDA and international regulatory laws and standards

+ Travel required up to 20% (both domestic and international)

**Must Have: Minimum Requirements**

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

+ Bachelors degree in a science discipline such as Mechanical, Materials, Biomedical Engineering or related technical field

+ 7+ years experience or an advanced degree with 5+ years experience

**Nice to Have**

+ Endovascular (Neuro) knowledge and experience

+ Test method validation and statistical expertise

+ Leadership experience

+ Experience with design history remediation, test method validation, statistics

+ Bachelors degree in Mechanical or Biomedical Engineering with 10+ years engineering work experience in implantable medical devices

**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: 2021-01-08 Expires: 2021-02-14
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Principal R-D Engineer

Irvine, CA 92604

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