Systems/Software Verification Test Engineer in Concord, CA at HUNTER Technical Resources

Date Posted: 10/17/2020

Job Snapshot

Job Description


We have a client in Concord, CA that is looking for a System/Software Verification Test Engineer. 

Responsibilities: 

  • assuring projects meet customer expectations, and regulatory requirements
  • Provide guidance to engineering staff and ensure that design control requirements and being met in an effective manner
  • Provides input to design and manufacturing documentation to ensure that the resulting products can be adequately manufactured and tested.
  • Provide guidance on FDA compliance and procedures
  • Assist in the development and maintenance of company procedures for design control, change management, risk management, test method validation, process validation and related areas of the quality management system
  • Perform white box testing on medical device systems.
Requirements
  • Bachelor’ s or Master’ s in Computer Science, Software Engineering, Biomedical Engineering or related field
  • MUST have experience with medical device testing 
  • MUST have experience with systems level testing
  • MUST have experience with white/black box testing
  • Thorough understanding of FDA Quality System regulations in relation to computer system validation
  • Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements
  • Functional Testing Experience

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