Sr. HW Test Engineer

Mountain View, CA

Posted: 03/04/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008485

Job Summary 

This company is a publicly held medical device company focused on the design, manufacture and marketing of Magnetic Resonance Image Guided Radiotherapy devices. We are looking for a Senior Hardware Test Engineer individual to join the QA team.  This position will report to the Director Development QA.  Responsibilities 

  • Provides quality input and oversight to new product introduction, design transfer, installation and change control including requirement specification and quality V&V documentation.
  • Assist with the development of fault tree analysis, FMEA, and risk analysis.
  • Create / modify, review, and execute verification and validation plans, cases / runs, and reports for the company RF Coils and Hardware components.
  • Perform PCB schematic and layout reviews to catch issues prior to board release
  • Work with HW developers, PCB Layout engineers and other teams to identify, document, and lead any rework efforts of PCBs and associated assemblies.
  • Conduct system level tests against specifications for product feasibility and development.
  • Document all V&V activities to support final acceptance of the medical device product, including all related defect entry, tracking, and fix verification. 

Education, Experience, Skills 

  • Minimum BSEE, MSEE or equivalent experience
  • Minimum 8+ years of experience in V&V, preferably in a Medical Device
  • Experience with Radiofrequency (RF) related system, Gradient Systems and MRI Coil design
  • Solid experience with PCB schematics and design process
  • Experience with state of the art PCB design tools: Altium preferred
  • Experience with low-noise systems including noise mitigation and management
  • Experience with electromagnetic simulation/optimization software such as Sim4life and Faraday a plus
  • Ability to work effectively as part of the diverse team including physicists, scientists, and engineers in a fast-paced environment
  • Excellent written and verbal communication skills
  • In depth working knowledge of 21CFR 820, ISO 13485, ISO 14971, and IEC60601-2-33.
  • Knowledgeable about QA methodologies related to regression testing, ad hoc testing, functional testing and verification of calculations, user interface testing, and integration testing
  • Travel may be up to 10%

This company provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status or genetic information. 


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