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Principal Quality Engineer CAPA - Hybrid Remote - Miami Lakes, FL at Medtronic in Miami Lakes, Florida

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

Careers That Change Lives

In this exciting role as a Principal Quality Engineer you will be responsible for managing Non-conformance process, provide CAPA support as specialist, and support the successful implementation of projects and/or management of activities to define, design, develop and deliver new processes, quality improvement and change initiatives.

Mechanical Circulatory Support

The Mechanical Circulatory Support Operating Unit is responsible for Medtronic's heart pump program. Called the HeartWare™ HVAD™ System, this business provides a left ventricular assist device (LVAD) that helps patients' hearts pump and increases the amount of blood that circulates through their bodies. The HVAD System features the world's smallest, commercially available, centrifugal flow pump.

A Day in the Life

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


  • Looking for a highly organized, quick learning individual with strong communication skills that can work independently as well as collaborate well with various cross functional stakeholders.
  • 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.
  • Applies statistical methodology and implementing process improvements.
  • Presenting technical data to groups within and outside the organization

This position is an office based position in Mounds View, MN and will allow for a hybrid work capacity

Must Have: Minimum Requirements: To be considered for this role, please ensure the minimum requirements are evident on your resume.


  • Bachelor's 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:


  • Master's degree preferred
  • ASQ-CQE, CQA, CBA or equivalent certifications
  • DRM certification or training
  • Medical device experience; or experience in a regulated environment
  • Proficient in design controls
  • Strong technical skill in risk assessments, process validations, method validation and root cause analysis
  • Strong analytical skills
  • Excellent communication skills
  • Ability to work effectively within team and across functions

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. Let's 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)

Travel to suppliers or other Medtronic facilities as required: No travel required.

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here . This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .





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