Reliability and Failure Analysis

Quality Design & Engineering

Our Quality Engineers have responsibility for all Quality related aspects of the project. This includes hazard analysis activities, creating and managing the Quality Engineering deliverables, coordinating safety agency marking and regulatory compliance, ensuring Project compliance to internal and external standards, and coordinating design verification test activities.
Additionally the Quality Engineer ensures that the Design History File (DHF) content is complete and meets all ISO requirements.
Areas of Expertise:

  • Ensure Project Plan meets Operating Procedures, FDA Quality System Requirements (QSR), and ISO Requirements
  • Leads Hazard Analysis Meeting
  • Identify and document product requirements related to Safety agency and regulatory requirements
  • Coordinate Safety Agency Review
  • Supplier Assessment and Qualification
  • Represents Quality at Material Review Board (MRB)

Test Design & Engineering

Our Test Engineering team is capable of developing a complete test package starting with In Circuit Test (ICT) and board level tests through to functional system level tests.We can help define test accuracy ratios, develop test procedures, and generate complex, fully automated test systems that are appropriate for the production volume and test time requirements. Our Test team is also capable of supporting IQ/OQ/PQ requirements and fully supports line validation. We put our test experience and capabilities to work to ensure an effective test solution is in place.
We design and develop fully automated test racks to perform functional and final test of product on the production line. Automated test systems that we architect and design not only consider test accuracy, coverage, production volume and reliability, they also collect and provide data to satisfy the Design History File (DHF) requirements.
Our areas of expertise include:

  • Automated Test Equipment (ATE) Development
  • Development of Testable Requirements
  • Product Definition for Testability and Manufacturability
  • Board Level Test Development
  • System Level Test Development
  • Functional Testing
  • Evaluation of Equipment for Testing
  • LabVIEW and LabWindows™ /CVI Development