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System Engineer

3 months ago

Bengaluru, India SFO Technologies Full time

Systems Engineer



Responsibilities:

  • Ensure that device development meets targeted clinical application through systematic conversion of product requirements into systems solutions that meet technical, schedule and cost constraint
  • Evaluate device use cases to define system requirements and evaluate technical tradeoffs
  • Define Security and compliance requirements for the product; ensure system meets these requirements
  • Participate/Lead risk assessments and develop mitigation plans to ensure safe operation of the product
  • Participate in strategic discussions and own the technology development for the future generation of the product
  • Manage, track and upgrade hardware and software configuration of system / sub-system set-ups in the labs
  • Collaborate with quality and regulatory colleagues to ensure compliance with corporate, business unit and global standards applicable to the products



Essential Qualifications

  • B.E. from reputed university in Computer Science, Electronics, Biomedical, Instrumentation Engineering
  • 3 to 5 years in product development of complex electro-mechanical devices controlled by SW
  • Able to work with software and firmware teams to develop the algorithms for controlling the electromechanical components (like heater, pneumatic and hydraulic valves, and reading the sensors)
  • Working knowledge of Model based systems engineering approaches, MBSE tools knowledge like MATLAB, Enterprise architect, Cameo
  • Able to develop the treatment parameters for Hemodialysis and peritoneal dialysis
  • Able to write system requirements for performances, able to test and confirm the components performance for temperature, flow, pressure, bubble detection etc.
  • Knowledge of medical device quality and regulatory standards (ISO 13485, ISO 14791, IEC 60601, IEC 62304, etc.)
  • Strong written and verbal communication skills, with attention to detail and thoroughness
  • Able to work in direct, cross-functional and cross-cultural teams, with strong influencing skills
  • Able to participate in late evening and/or early morning calls
  • Self-starter, strong work ethic and initiative in accomplishing objectives, and delivering in ambiguous environments


Desired/Preferred Qualifications:


  • Working knowledge of define/collection of system requirements especially as applicable to healthcare sector
  • Working knowledge of hardware and electromechanical engineering concepts (microprocessors/microcontrollers, wired/wireless communications, motors, sensors, valves, fluid circuits, etc.)
  • Full product lifecycle experience (concept/prototyping, development, test, release, post release)
  • Knowledge of Agile methodology for software / product development
  • Knowledge of creating automated testing infrastructure