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Senior Hardware Reliability Engineer, Medical Devices

Company: Amazon Lab126
Location: Sunnyvale
Posted on: June 6, 2021

Job Description:

We are a smart team of doers that work passionately to apply cutting-edge advances in technology and to solve real-world problems that will transform our customers' experiences in ways we can't even imagine yet. As a Senior Hardware Reliability Engineer, you will engage with an experienced cross-disciplinary staff and outside partners to drive key aspects of product definition, execution and test. You must be responsive, flexible and able to succeed within an open collaborative peer environment.

You will be responsible for the test validation of our medical devices. You should have a good understanding of Reliability statistics/Reliability tests and/or solid understanding of medical devices to influence design for reliability to:

  • Identify and validate product risks, including but not limited to electrical system, mechanical system, RF system, acoustic system, and work with design teams to mitigate them
  • Define test methodology and test coverage to assure product reliability
  • Provide hands-on experimental design and execution
  • Perform reliability prediction of failure mechanisms on products under development and products in the field

Successful candidates for this role will have demonstrated sound working knowledge of Medical Devices, Quality Management Systems, FDA regulations, and good understanding of the entire product lifecycle management in a medical environment.

  • Bachelor's degree in Biomedical Engineering, Chemical Engineering, Reliability Engineering, Mechanical Engineering, Materials Science, Electrical Engineering, Physics or related fields or equivalent experience
  • 7+ years of experience in reliability engineering or medical devices
  • Experience with hardware reliability testing such as vibration & shock testing, fatigue testing, electrical stress testing, ESD testing, and thermal stress testing
  • Capable to use quality and reliability tools such as FMEA, Fishbone, DOEs and Six-sigma methods to build reliable products
  • Experience in data analytics, statistical analysis. Able to perform reliability analysis such as lifetime analysis, accelerated factor studies, reliability modeling
  • Familiar with data analysis tools such as JMP, Reliasoft, Matlab, Minitab or Python
  • Reliability program management experience
  • Strong communication skills in writing and presenting
  • Able to deep dive into reliability problems and resolve them independently. Master's or PhD degree
  • Knowledge of medical devices ISO and FDA standards and related compliance processes.
  • Knowledge/familiarity with the pharmaceutical, biotech and/or medical device industries
  • Experience with IC/Semiconductor reliability, board reliability, display reliability, IC package types, board design and layout.
  • Experience with failure analysis techniques: Electrical debug, Cross sectioning, dye and pry and microscopy
  • This position will require some international travel

Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit

Keywords: Amazon Lab126, Sunnyvale , Senior Hardware Reliability Engineer, Medical Devices, Other , Sunnyvale, California

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