Sr. SW verification Engineer

East Bay, CA | Direct Hire

Post Date: 12/15/2017 Job ID: 6000 Industry: Software/Hardware

Summary:

The Senior Software Verification Engineer is part of the Software Development team and focused on software testing starting from early design stages to final product implementation, ensuring that all product and process requirements are met. This person will interact with other internal users of the system to train and guide them on new software features. Additionally, this person will oversee software configuration management on the test systems and software labs.

 The ideal candidate will have a strong background in software testing with relevant experience in medical device quality system and design control regulations, including specification, risk analysis, verification, and validation. Experience within the Radiation Therapy domain is desired, but not required. The candidate will engage on any and every issue necessary to ship products to customers of the highest quality and reliability.

 Essential Functions:

  • Lead software verification from early design phase through to release, for new product development and continuing engineering projects
  • Support software requirement definition and reviews to ensure they are relevant, unambiguous, and verifiable
  • Participate in software risk assessment and software design reviews
  • Write test plans and test protocols, and perform verification tests and conduct analysis of the test results to ensure that the software performs to documented requirements
  • Continuously improve verification tests with feedback from early informal runs as well as from peer reviews, maintaining traceability to requirements
  • Report any software issues that are identified during testing, help analyze and debug software to define a resolution, and verify the resolution
  • Support training of other system users on new software features being deployed
  • Support creation and maintenance of Software development and verification SOPs
  • Manage software configuration of test systems and labs
  • Mentor and coach junior software verification engineers

 

 

 Job Requirements:

  • Bachelor’s degree in Electrical Engineering, Computer Science, or related field, or commensurate industry experience
  • A minimum of 7 years of professional experience in a Software Verification Engineer role within complex projects involving software and hardware integration
  • Medical device software verification testing experience through a complete Software Life Cycle
  • Experience working within an FDA regulated medical device industry and familiar with software documentation for FDA submissions
  • Working knowledge of the FDA Quality System Regulation, IEC 62304 and IEC 60601-1-X standards
  • Excellent verbal and written communication skills, and the ability to work effectively on project teams
  • Familiarity with tools for requirements, issue, and test management (e.g. Helix, Rational)
  • Familiarity with version control systems (e.g. Git, TFS)
  • Experience working with Radiation Therapy medical devices is a plus

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