Product Assurance and Reliability Engineer

7 days ago

Irvine, California, United States Masimo Full time
Job Description

The Product Assurance and Reliability Engineer II position at Masimo is a multifaceted role that requires a strong understanding of basic science and engineering principles.

An individual in this role will be part of the Product Assurance department, working to investigate, test, and provide expertise in the effort to improve the quality and reliability of Masimo's product portfolio.

The role requires a person with experience in one or more of the following specific areas: microelectronic assembly processes and materials, materials compatibility testing, adhesive and material properties testing and analysis, semiconductor packaging, failure analysis, and/or reliability performance testing per applicable JEDEC, IPC, and Military standards.

An individual in this position is expected to contribute to new product development, post-market quality, and provide technical input to associated process development teams.

This role will ensure products meet defined quality and reliability standards and contribute to failure analysis and reliability engineering as needed.

Duties and Responsibilities
  1. Contribute to new medical microelectronics technology design, process, and material decisions through the development of quality and reliability risk assessments leveraging historical data, analytical modeling capabilities, and fundamental technical knowledge.
  2. Provide statistical analysis of quality and reliability data collected from assembled products and/or test vehicles for the prediction of product field reliability performance.
  3. Provide technical inputs on the design of medical microelectronics assembly test vehicles and semiconductor test devices.
  4. Design and execute experiments to identify new failure mechanisms, determine fundamental technology envelopes, and define root cause solutions.
  5. Develop and execute efficient, robust, and salient technology certification strategies and plans.
  6. Clear communication of results, their impact, associated risks, and recommendations within the quality and reliability community and with partner organizations.
  7. Support early stage pilot production as part of technology transfer to high volume factories.
  8. Perform failure analysis using x-ray, DSC, SEM, and other analytical equipment.
  9. Implement HALT, HAST, JEDEC testing protocols.
  10. Support pilot manufacturing line(s) by performing quality/product assurance reviews and/or root cause analysis.
  11. Contribute to the development, implementation, and maintenance of SPC and other statistical techniques to ensure manufacturing remains in control.
  12. Assist identifying metrics and test methods improving the control of manufacturing processes and/or product reliability.
  13. Maintain skills and abilities in product assurance and reliability engineering relevant to industry practices.
Minimum and Preferred Qualifications and Experience

Minimum Qualifications:

  • 3 years' Product Assurance and Reliability Engineering experience or equivalent.
  • 2 years' experience in medical device design, development, and process development or equivalent.
  • Demonstrable ability to apply JEDEC, IPC, and other industry standards toward the characterization of the reliability performance of semiconductor devices, components, and/or medical microelectronic assemblies.
  • Experience in medical microelectronic device assembly, board-level process technology, and/or semiconductor fabrication processes.
  • Experience in empirical data collection and statistical data analysis, reliability statistics, and design of experiments.
  • Experience with the testing and analyzing of different materials and adhesives properties.
  • Statistical analysis of quality and reliability data extracted from products and assembly test vehicles to predict field reliability performance.

Preferred Qualifications:

  • Experience working with 21CFR820, ISO 13485 and 14971 requirements.
  • Familiarity with a range of imaging and analytical lab test equipment such as x-ray imaging, SEM/EDX, acoustic microscopy, thermal analysis (DSC, TGA, DMA), chemical analysis (FTIR/ATR, GC-MS, GPC/HPLC).
  • Capable of organizing and performing engineering/scientific data analysis.
  • Experience with statistical software JMP, MiniTab, Design Expert or equivalent.
  • Experience with plastic molding processes.
  • Demonstrated strength in technical and analytical problem solving.
  • Require minimal guidance in daily activities.
  • Demonstrate the ability to seek opportunities to improve product quality and reliability.
  • Ability to clearly communicate.
  • Ability to work in a team setting with people from a wide range of backgrounds.
  • Be a positive and influential participant in a cross-functional environment.

Education:

B.S. in Mechanical Engineering, Material Science, Chemical Engineering, Electrical Engineering, Chemistry, or Physics.

Compensation:

The anticipated range for this position is $75,000 - $113,000. 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.

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