Engineer II, Product Assurance & Reliability

Job Summary

The Product Assurance and Reliability Engineer II position at Masimo is a multifaceted role that requires a good understanding of basic science as well as engineering. 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. As a result, a person in this position should be able to contribute in all stages of product lifecycle (e.g. Design, Verification and Validation Testing, Production, and Post‑Market).

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

• Contribute to new medical microelectronics technology design, process, and material decisions through the development of quality and reliability risk assessments leveraging historical data, analytical modelling capabilities, and fundamental technical knowledge
• Provide statistical analysis of quality and reliability data collected from assembled products and/or test vehicles for the prediction of product field reliability performance
• Providing technical inputs on the design of medical microelectronics assembly test vehicles and semiconductor test devices
• Designing and executing experiments to identify new failure mechanisms, determine fundamental technology envelopes, and define root cause solutions
• Development and execution of efficient, robust, and salient technology certification strategies and plans
• Clear communication of results, their impact, associated risks, and recommendations within the quality and reliability community and with partner organizations
• Supporting early stage pilot production as part of technology transfer to high volume factories
• Performing failure analysis using x-ray, DSC, SEM, and other analytical equipment
• Implement HALT, HAST, JEDEC testing protocols
• Support pilot manufacturing line(s) by performing quality/product assurance reviews and/or root cause analysis
• Contribute to the development, implementation, and maintenance of SPC and other statistical techniques to ensure manufacturing remains in control
• Assist identifying metrics and test methods improving the control of manufacturing processes and/or product reliability
• Maintain skills and abilities in product assurance and reliability engineering relevant to industry practices

• 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

• Experience working with 21
  
  CFR
  820, 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…