Source description
About the role
Mandatory : - Hands experience in Verification & Validation activities for Medical/Health products from beginning of NPI/NPD (Complete design life cycle) - Good in Analyze requirements, assess early are these requirements are testable or not. Assess if any fixtures or equipment's required in advance. - Hands experience in preparing System verification produces/protocol, execute tests and product test results & reports. - Have Knowledge on standards like IEC60601-1-2 (EMI/EMC), ISO 80601-2-13, Biocompatibility standards ISO 18562 & ISO 10993. Capable to guide and execute the standards testing with External labs like TUV/ UL / Intertek and mitigate the issues. - Having experience in detailed discussion with external labs/testing agencies to enquire Lab facility required, certifications for the Medical devices and select & Manage testing. - Drive team to identify issues from verification, log the issues in tools like JIRA or ClearQuest, Drive defect control board, review with crossfunctional team and verify the resolutions. - Have hands on experience on Reliability assessment and demonstration reliability for hardware & software. - Working experience in Ventilator or Anesthesia or Dialysis machine products will be an advantage. - Hands experience in Verification & Validation activities for Medical/Health products from beginning of NPI/NPD (Complete design life cycle) - Good in Analyze requirements, assess early are these requirements are testable or not. Assess if any fixtures or equipment's required in advance. - Hands experience in preparing System verification produces/protocol, execute tests and product test results & reports. - Have Knowledge on standards like IEC60601-1-2 (EMI/EMC), ISO 80601-2-13, Biocompatibility standards ISO 18562 & ISO 10993. Capable to guide and execute the standards testing with External labs like TUV/ UL / Intertek and mitigate the issues. - Having experience in detailed discussion with external labs/testing agencies to enquire Lab facility required, certifications for the Medical devices and select & Manage testing. - Drive team to identify issues from verification, log the issues in tools like JIRA or ClearQuest, Drive defect control board, review with crossfunctional team and verify the resolutions. - Have hands on experience on Reliability assessment and demonstration reliability for hardware & software. - Working experience in Ventilator or Anesthesia or Dialysis machine products will be an advantage. Specific Software/ IT Knowledge require: DOORs, JIRA, ClearQuest, HP ALM, Any PLM tools, Requirement management tools Preferred Companies/ Industries: Health care or Medical equipment - Verification & Validation
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