System Validation Engineer

Maven Workforce  •  Moundsville, WV

5 - 7 years experience  •  Medical Devices & Diagnostics

$80K - $90K
Posted on 11/18/17 by Surya Vamsi
Maven Workforce
Moundsville, WV
5 - 7 years experience
Medical Devices & Diagnostics
$80K - $90K
Posted on 11/18/17 Surya Vamsi

Job Title: System Validation Engineer

Location: Moundsville, WV

Position: Full-time

Experience Req: 6 plus years

Description: 

  • A System Validation Engineer supports product development efforts as a key member of program teams by leading system-level validation activities to ensure that Customer products perform as designed and conform to user needs and intended uses

Primary Skills:

  • Develops system validation plans and test protocols. Develops detailed test procedures for system level testing and sub-system verification
  • Conducts and documents those tests
  • Reviews and analyzes design input requirements from a testability standpoint 
  • Performs technical planning and performance evaluation studies, conducts technology assessment activities, analyzes system integration issues
  • Experience with Design Verification Test Method documentation and Test Method Validation
  • Ability to apply statistical analysis as related to sample sizes to be used for design validation
  • Support system integration and effectiveness analyses for total systems
  • Evaluates, recommends, learns, trains about new validation and test tracing tools
  • Identify, propose, and assist in the implementation of process improvement initiatives
  • Evaluates prototypes formally and informally through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirement
  • MS Office

Secondary skills:

  • Ability to communicate effectively in multi-discipline, cross-cultural environment and levels of organization
  • Strong problem-solving skills and efficient management of time and resources 
  • Prior experience in a medical device manufacturing environment
  • Experience managing and mentoring other engineers
  • Work closely with partners to ensure adequate coverage between system integration, system verification, and system validation efforts
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Lead and provide work direction to technicians executing test activities. Ensure the test team understands the testing to be performed and correctly executes these activities in a timely manner.

Industry Skills:

  • Medical

Education: 

  • Bachelor of Science in Biomedical Engineering, ElectricalEngineering, a related engineering field

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