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Principal Quality Engineer

Fridley, MN 55432
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Principal Quality Engineer


Fridley, Minnesota, United States

Requisition #:


Post Date:

Dec 11, 2020

**Careers That Change Lives**

In this exciting role in Medtronics Post Market Surveillance (PMS) process, the **Principal Quality Engineer** will join the team in developing and executing Post Market Surveillance activities. This individual will partner with other teams such as Clinical Research, Regulatory Affairs, Quality/Reliability, Product Development, Medical Safety, and Statisticians to perform Post Market Product Surveillance.

**The Restorative Therapies Group** develops 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.

**Neuromodulation** delivers innovative therapies and solutions for neurological diseases, pain, and spasticity.

**A Day in the Life**

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

+ Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

+ Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

+ Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

+ Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

+ Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

+ May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

+ Author PMS 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.

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

+ May interface with regulatory agencies to discuss details of the PMS report.

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

+ Critically evaluate surveillance data and collaborate with cross functional team to identify risks and mitigation plans.

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

**Nice to Have**

+ Previous experience in the application of in-depth therapeutic and device knowledge.

+ Analyzes complex surveillance and trending methods and improves, changes, or adapts existing methods.

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

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

+ Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills.

+ Proficiency in word processing tools, spreadsheets, and/or database applications (e.g., MS Word and Excel)

+ High attention to detail and accuracy.

+ Ability constructively respond to feedback/comments/inquiries.

+ Prior Medical Device

+ Six Sigma and/or LEAN certified (green belt or black belt)

**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: 2020-12-24 Expires: 2021-04-25
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Principal Quality Engineer

Fridley, MN 55432

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