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System Verification and Validation

5.00 to 10.00 Years   Bangalore   04 Jun, 2021
BRAIN HUB SERVICES LLP
Job LocationBangalore
EducationNot Mentioned
SalaryRs 4.5 - 9 Lakh/Yr
IndustryAutomobile / Auto Ancillaries
Functional AreaEngineering Design / Construction,Site Engineering / Project Management
EmploymentTypeFull-time

Job Description

We have opening forSystem Verification and ValidationLocation:BangaloreBudget:5to 10 years

  • Diploma or bachelors degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
  • 5 to 10 yrs. of experience in System Verification testing System functionality and performance.
  • Relevant technical testing/reliability experience in electro-mechanical, electrical testing of Medical Devices.
  • An understanding of test methods and processes as well as the methods used to verify product in the realms of; mechanical, electrical, functional and environmental testing environments.
  • Basic hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data
  • Experience in Tools like Minitab( Data Analysis) / JIRA ( Defect ) / ALM ( test Environment) etc.
  • Understanding of hardware and software product design methodologies and test practices.
  • Experience in medical device or similar product development, design verification/validation, system integration (hardware/Subsystem/Software), risk management, reliability engineering, process validation and Quality systems
  • Basic understanding of and adherence to FDA,MDD/MDR, ISO and IEC design control procedures, regulations and standards.
  • Self-motivated with good interpersonal skills.
  • Ability to follow instructions clearly.
Roles & Responsibilities:Execute, perform, summarize, report out verification test activities of components to a full system device: Which includes but not limited to:
  • Understand URS (User requirements) / System Requirements and prepare the System Level Test cases and Prepare test procedures.
  • Perform the Functional and Performance testing for the product.
  • Support and perform Design Verification activities.
  • Perform Installation/Operational/Performance Qualification Protocols
  • Prepare Traceability Matrices and Final Reports.
  • Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.
  • Follow Test instructions and Test protocols.
  • Follow instructions clearly from Design engineers during Test execution.
  • Support Design engineers in Test fixture creation, building up & tearing down Test equipment.
  • Support Lab logistics and Support Calibration activities.
  • Diagnose, isolate and investigate problem reports and defects.
  • Works with external test houses (such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute & consolidate the reports
  • Ensure good documentation and Good Manufacturing practices are followed in the Verification Process
  • Experience in IEC basic safety, EMI-EMC standards
  • Interacts with design team to resolve tests-related technical issues.
  • Presents the findings / objective evidences and able to present with rationale with applicability / exclusions
  • Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.
Tools: Microsoft office, Minitab( Data Analysis) / JIRA ( Defect ) / ALM( test Environment)

Keyskills :
iso 14971assertion based verificationrtl verificationsystem verificationdesign controlrequirements verificationvalidationpremarket approvalgampcleaning validationaseptic processinggxpsoftware verificationconcept of operationsce marking

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