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Sr Systems Engineer

8.00 to 12.00 Years   Bangalore   12 Oct, 2021
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

  • Work with customer-facing team members (human factors and voice-of-customer specialists) to understand user needs and convert them into high-level product specifications. Develop detailed technical requirements, and ensure accurate flow-down to sub-system requirements, design implementation.
  • Discuss with system verification engineers to ensure that the system requirements are adequate and verfiable
  • Coordinate the team effort of interdisciplinary engineers (electronics, mechanical, firmware, and chemical) for design of the product and provide technical expertise for technical tradeoff decision making.
  • Define the use condition and use cases to develop the system features. Define the logics and provide inputs to the software team for implementing the use cases.
  • Perform risk assessment for the product and develop risk mitigation strategies.
  • Identify applicable regulatory and industry standards and ensure product can satisfy requirements of these standards.
  • Work with quality/reliability engineering to identify and minimize sources of technical and practical risk, and ensure the product meets medical device-related safety standards.
Must Have: Minimum Requirements
  • 8+ years experience in the healthcare domain, with knowledge of medical device-related standards such as ISO 13485, US FDA s 21 CFR 820, IEC 60601, IEC 60068 and ISO 10993
  • Basic understanding of biomedical concepts (human anatomy, disease, diagnostics, therapies)
  • Working knowledge of dialysis therapy
  • Basic understanding of biomedical concepts (human anatomy, disease, diagnostics, therapies)
  • Basic understanding of chemistry concepts (working knowledge of water purification technologies, including filtration, reverse osmosis, carbon beds, and ion exchange processes)
  • Experience in verification of medical products with involvement in multidisciplinary techniccal challenges (electromechanical or biomedical).
Additional Information
  • Data og oszenia: Oct 5, 2021
  • Podr e: No
,

Keyskills :
risk assessmentpilot projectsenvironmental impact assessmentiso 10993iec 60601risk mitigationuse cases21 cfrreverse osmosisiso 13485water purificationion exchange

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