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1+ months

Principal Quality Engineer

Medtronic
Fridley, MN 55432
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Principal Quality Engineer

Location:

Fridley, Minnesota, United States

Requisition #:

21000RE8

Post Date:

Oct 25, 2021


**Careers That Change Lives**


A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.


In this exciting role as a **Principal Quality Engineer,** in Medtronics Post Market Surveillance (PMS) process within the Risk Management organization, the incumbent will contribute to the Post Market Surveillance report writing process to ensure compliance to regulations and expectations of Regulatory Bodies. This is a scientific (engineering, technical, medical) writing position. This individual will partner with other teams such as Quality/Realiability, Clinical Research, Regulatory Affiairs, Product Development, Medical Safety and Statisticians to collaborate and execute tasks in a timely manner.


**A Day in the Life**


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


+ Applies statistical methodology and implementing process improvements.

+ Presenting technical data to groups within and outside the organization.

+ Writes and edits Product Surveillance plan and report documents.

+ Interface with key functional areas to obtain necessary information and documents required for the development of PMS Plans Reports.

+ Develop therapeutic and device operation knowledge and apply this knowledge to post market surveillance of products.

+ Investigates product performance signals from trend reporting and completes reporting and escalation decisions

+ May participate and/or facilitate meetings to meet objectives.

+ Provide input and feedback to ensure clear, concise complete surveillance reports.

+ Collaborate with cross-functional team to assure high quality and successful completion of deliverables

+ May collaborate with cross functional team to identify risks and mitigation plans

+ report on schedule, timelines and deliverables

+ Participate in process improvement initiatives


**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 Masters Degree Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.


**Nice to Have (Preferred Qualifications):**


+ Masters degree preferred

+ ASQ-CQE, CQA, CBA or equivalent certifications

+ Medical device experience; or experience in a regulated environment

+ Experience working with suppliers and/or contract manufacturers

+ Strong analytical skills

+ Excellent communication skills

+ Ability to identify customer/stakeholder requirements, and constructively respond to feedback/comments/inquiries

+ Analyzes complex issues and significantly improves, changes, or adapts existing methods.

+ Ability to work with very little direction towards predetermined long-range goals and objectives. `

+ Proficient knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states, Neuromodulation therapies and technologies

+ Ability to achieve objectives and milestones through identification and implementation of work plans and measurements.

+ Ability to identify and adapt to shifting priorities and competing demands

+ knowledge and understanding of Good Clinical Practices, Quality Management Systems, Risk Management and regulatory standards

+ Strong ability to determine and pursue courses of action necessary to obtain desired results


**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.

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

Medtronic
Fridley, MN 55432

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