Job Summary:

Responsible for performing failure analysis of customer returned products, newly manufactured products, and prototype products, with the intent of root cause isolation of full device system issues or sensor and cable issues down to the circuit board, component, or process level.  Works closely with Compliance, Regulatory, R &D Engineering, Operations and QA at various levels within the organization to understand the root cause of product failures and identify product improvements.

Duties & Responsibilities:

Perform root cause analysis using a wide range of techniques and engineering principles to tackle challenging issues with Masimo products, including devices, cables, and sensors. Analyze and troubleshoot electronic circuits at system, module, and component level using circuit schematics and layouts. Investigate products utilizing analytical instruments and techniques: electrical test equipment, CT X-ray scanning, optical microscopy, component cross sectioning, thermal imaging, FTIR spectroscopy, energy dispersive spectroscopy, and environmental chamber testing. Collaborate with cross-functional teams to recreate failure modes that are intermittent or hard to replicate. Track and trend product failures to generate reports, working with engineering to report new/trending failure modes. Collaborate with QA, R&D Engineering and Manufacturing functions to report product status and recommendations to improve product performance. Document and report any significant findings with photographs or samples to appropriate QA, R &D Engineering, Manufacturing, and Operations personnel. Identify root cause of customer returned product failures using engineering principles and electrical test equipment. Identify potential Customer training issues and propose solutions. Promptly report all field failures and Customer complaints per the Masimo Quality System. Follow-up to ensure closure of product and training issues. Monitor Customer/Technical support process and procedures and implement changes to optimize the process. Maintain regular attendance in accordance with current position needs and department expectations as defined by divisional management. Perform other duties and projects as assigned. 

 

Minimum & Preferred Qualifications and Experience: 

 

Minimum Qualifications:

Quality Control testing experience, preferably for a Medical Device Company. Knowledge and experience in ISO-9000 requirements. Knowledge of biohazard products and procedures; knowledge of biohazard programs and disposal compliance requirements. Working knowledge of electrical testing and electrical testing equipment, such as microscopes, digital cameras, calipers, digital multimeters, oscilloscopes, and other equipment as needed for testing and troubleshooting. Working knowledge of electrical engineering or related device level, circuit board level, and component level troubleshooting for root cause failure analysis investigations of customer returned product. Experience in data entry into a Database program and be able to manipulate data for reporting with MS office applications. Good communication skills both verbal and written, and detailed oriented.

 

Preferred Qualifications:

Experience with FDA regulations. Prior experience in repair operations and support services.

 

Education:

 Bachelor’s degree, preferably in Electrical Engineering, or equivalent, is required.  A combination of equivalent education and related experience will be considered in lieu of a Bachelor’s degree.

Compensation: The anticipated range for this position is $65,000 - $97,000.  Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Physical requirements/Work Environment 

This position primarily works in an office environment. It requires frequent sitting, standing and walking.  Daily use of a computer and other computing and digital devices is required.  May stand for extended periods when facilitating meetings or walking in the facilities.  Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. 

 

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.  Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.