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The candidate will perform root cause analysis on clinically applied medical device global customer returns to ensure high levels of quality, reliability, safety, and efficacy.  A microscopic visual inspection and functional/mechanical evaluation in accordance with the Master Device Inspection Plan of each product return will be conducted in compliance with GMP, ISO, QSR, FDA, and International Regulatory requirements.  Additional responsibilities include independently coordinating the investigation process with Engineering and/or Research and Development.  The results of these analyses will be formally documented and incorporated into written customer communications.

  • Test and thoroughly evaluate devices of various degrees of complexity to determine root cause analysis within a closely monitored time frame.  
  • Identifying the appropriate test method/regiment from existing Standard Operating Procedures for complaint sample evaluation, execute the method, and interpret the data (technical) for definitive root cause analysis determination.  Test methods may include dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards.
  • Replicate reported failure mode with bench top or in vivo test methods and document observations accordingly.
  • Initiate and distribute Corrective Action Requests to Manufacturing or Engineering Departments as needed.
  • Prepare technical investigation reports based on results of evaluation and/or review of the manufacturing plant reports to be documented in the QA (Quality Assurance) Department complaint database and incorporated into customer response letters.  
  • Certification with OSHA’s BloodBorne Pathogens Standard 29 CFR 1910.1030 and adherence to Corporate and Local Environmental Health and Safety Policies.
  • Maintain the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union), Canadian Medical Device Regulations, Japan MHLW, China SFDA and Australian Regulations.  

  • Associate Degree in a technical curriculum and equivalent industry experience.
  • Minimum one year experience in a laboratory environment or academic knowledge in scientific research methods.
  • Experience with medical devices preferred but not required.
  • Time management skills.
  • Critical independent thinking and timely follow up.
  • Excellent written and verbal skills necessary.
  • Strong operating knowledge of Word, Excel and PowerPoint computer applications
  • Knowledge of quality control concepts desirable
  • Detail oriented and highly organized
  • Demonstrated ability to communicate clearly both verbally and in writing 

Lab Environment:  Required to perform laboratory activities within a biohazard laboratory setting requiring the use of personal protective equipment.  Frequent* sitting, walking, standing, and occasional* kneeling, crouching, crawling, balancing, stooping climbing.  Frequent* use of eye, hand and finger coordination in laboratory investigations and use of equipment.  Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.  Physical effort required by handling objects up to 20 pounds.

*Occasional:               Activity exists less than 1/3 of the time.
*Frequent:                 Activity exists between 1/3 and 2/3 of the time.

In order to be considered for this position, the above basic qualifications must be evident on your resume.



Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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. 


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.


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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.


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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


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