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Engineering
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19000KEL Requisition #

Careers That Change Lives

In this exciting role as a Sr Test Method Engineer, you will have the opportunity to work within the quality function on product development programs in the Structural Heart Business Unit. This role will focus on test method development and validation to support the emerging market of Transcather Mitral Valve therapy.


CVG

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. 


CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.


A Day in the Life


Responsibilities may include the following and other duties may be assigned


  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Job requires collaboration with cross-functional project team members as well as members of the QA extended team.

  • Actively participates in the development of in vitro test methods

  • Develops and leads test method and software validation strategies

  • Develop and document statistically sound sampling plans.

  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.

  • Statistical knowledge and Minitab experience. Demonstrated ability to document test data, analyze test results utilizing statistics, write clear and concise reports, and make recommendations to evaluate product.

  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.

  • May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.

  • Knowledge of GR&R demonstrates strong technical skills regarding development of Test Methods / TMV, inspection qualification methods, sampling plans, inspection techniques, critical attributes, process validation.

  • Tracking timelines and facilitating the required Design Quality Engineering deliverables; Guiding the successful completion of projects.

  • Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.


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 4+ years of work experience in Engineering and/or Quality OR Advanced Degree Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.

 

Nice to Have

  • M.S. degree in Engineering, Biomedical, Math, Physical Science, or equivalent field.

  • Knowledge of Six Sigma/DRM tools.

  • Experience with Solid works or other CAD applications

  • Familiar with regulations: FDA 21 CFR Part 820, Part 211, Part 4, ISO 13485.

  • Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints.

  • Fundamental understanding of designs and manufacturing processes to support designing, troubleshooting, testing, refining and qualifying the design to ensure the sustainable manufacturing of medical devices both internally and externally.

  • Experience in a regulated industry

  • Experience with Minitab or similar statistical analysis tools


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 up to 20% international and domestic

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