Job Description :
Role          :  System Engineer
Location   : San Diego, CA (Onsite) 
Duration :  1 Year Contract 

Client       : HCL AMERICA


Job Description:
  • Define and review system and sub-system level requirements.
  • Define interface protocol specifications.
  • Review software design specifications.
  • Create and maintain system traceability among customer needs, system, sub-system level requirements and risk management artifacts to ensure completeness and fully traceable design history file.
  • Review and maintain test traceability between requirements and risks to the test protocols.
  • Define, review and deliver some or all of the following:
  • Requirements Definition - User Needs, System Requirements, Subsystem Requirements
  • Risk Analysis, Evaluation and Control, Preliminary Hazard Analysis, Device Hazard Analysis, FMEAs, Risk Management Reports
  • Traceability Matrices
  • Bachelor of Science (M.S. preferred) in Biomedical Engineering, Electrical Engineering, Computer Science or equivalent, including relevant coursework and/or work experience in product development.
  • 8+ years of experience in product development (comprising electro-mechanical and software pieces).
  • Proficient with Medical Device regulations (IEC 62304, 21 CFR part 820.30-Design Controls, ISO 14971, ISO 13485).
  • Expert level requirement elicitation, analysis and documentation skills.
  • Expert with Preliminary Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA).
  • Ability to moderate requirements engineering discussions and work as a bridge among different engineering departments and global stakeholders.
  • Experience architecting and allocating requirements across multiple subsystems.
  • Experience setting up, configuring and using enterprise requirements management systems (e.g.: Jama, IBM DOORs) is a plus.
  • Strong written, verbal, interpersonal and presentation skills





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