Must have Bachelors in Biomedical Engineering, Mechanical Engineering, Software Engineering or a related field plus 8 years of postbaccalaureate experience in the job offered or related role in the medical device industry.br br Of the required experience, must have 2 years of experience in any of the following New Product Development NPD, Bone cutting, or Enterprise Architect Depth measurements using advanced tools.br br Of the required experience, must have 5 years of experience in the followingbr Requirements Management tools such as Doors, Cockpit, ALM, or equivalent requirements management system;br Test Management tools such as ALM, Cockpit, Enterprise Architect, or Zephier;br Perform Risk assessments per ISO 14971;br Develop design and development plan and design verification plan per ISO 13485.br Software Hazard analysis, code review and technical guidance.br Software design, development, unit testing and integration testing activities.br Whitebox Black box testing, test plan preparation, test script generation, code coverage analysis, test execution and peer review.br Defect analysis, defect tracking, regression testing, test reports generation and test closer activities.br Define Path for Automation Test Platform.br System and subsystem test case development and test execution.br Design and review of highlevel and lowlevel design of various modules.br SMART Requirement Analysis.br Software Development Life CycleSDLC.br STLC process application and implementation.br System Level Medical Device testing.br br Must be able and willing to travel domestic and international up to 10 of the time.

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