Systems Engineering Prof. 4

  • Location

    Norwood, United States

  • Sector:

    Business Professional

  • Job type:


  • Contact:

    Sonu Chouhan

  • Job ref:


  • Published:

    over 1 year ago

  • Expiry date:


The Systems Engineer will help will help the team design, develop and commercialize new Point of Care products. The talented and passionate individual will be heavily involved in hands-on integration, analysis, troubleshooting of prototype instrumentation / breadboards. The individual will also be responsible for documenting system and subsystem level components for medical diagnostic instruments.

Duties & Responsibilities:

  • Demonstrates proficiency in performing root cause analysis and leading troubleshooting activities related to failure mode and error analysis of a next generation type II medical device.
  • Leads the development of test plans and data acquisition in support of ongoing product development as well as informal (dry run) and formal (design V&V) testing of complex electro-mechanical, software-driven medical devices; responsibilities may include managing systems HW& SW integration, software loads and updates, configuration control, and test execution and reporting.
  • Works with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.
  • Specify, design, and develop test systems (hardware & software); ensure that all test systems and equipment are appropriately validated and controlled
  • Collaborates with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a medical instrument.
  • Work closely with all engineering disciplines, including Systems, Electrical, Mechanical, Disposables, and Software Engineering, as well as Project Management and Quality personnel, to verify and validate product designs.
  • Applies knowledge of regulations and standards including: FDA design controls, ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
  • Perform design reviews, FMEAs, risk / hazard analysis, establish technical requirements

Knowledge & Skills:

  • Minimum BS in Engineering (Biomedical or Mechanical) is required + a minimum of 8 years of relevant electromechanical medical device experience
  • Ability to understand complex system interactions and the effect on analytical performance
  • Proficiency with data acquisition, analysis and statistical techniques using Labview, MatLab, Minitab etc. Expert competency with LabVIEW is a plus
  • Experience in fluidics and designing small fluidic systems
  • Demonstrated understanding of product development considerations for tightly controlled manufacturing processes
  • Excellent understanding of medical device product development risk management methodologies
  • Knowledge of Design of Experiments (DOE), Design for Six Sigma (DFSS), Design for Manufacturing/Assembly (DFMA)