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Job Location | Navi Mumbai |
Education | Not Mentioned |
Salary | Rs 20 - 30 Lakh/Yr |
Industry | Medical / Healthcare |
Functional Area | R&D / Product Design,Embedded / System Software |
EmploymentType | Full-time |
Capable to understand the scope of work, estimate resources, build team, guide team members to complete the tasks. - Have Experience in verification of Medical equipment from the beginning of NPI/NPD (Complete design life cycle). - Have hands on experience on standards like IEC60601-1 and capable to write applicable requirements for the system. - Have Knowledge on standards like IEC60601-1-2 EMI/EMI, ISO 80601-2-13,ISTA, and Biocompatibility & ISO 80601-2-55 capable to guide and execute the standards testing and mitigate the issues. - Have working experience in Compliance scheme (CE) certification test and report generation - Have hands on experience on Reliability assessment and demonstration - Review the Schematic and Isolation diagram for ensuring the safety requirements - Drive team to identify issues from verification, log the issues, review with cross functional team and verify the resolutions. - Having experience in detailed discussion with external labs and testing agencies to enquire certifications for the Medical devices. - Coordination with NABL accredited external lab for EMI/EMC test, Mechanical tests and Environmental testing and get report. - Ensure verification Electrical designs/sub-systems integrated with mechanical & Software sub-systems are achieved by design team. - Have collaboration with Internal team and external team to bring best practices. - Report out to leadership about time line and quality of product periodically. - Good knowledge on Agile methodologies to drive SW verification execution - Able to manage lab equipment and engineering lab safety - Working experience in Ventilator or Anesthesia products will be an advantage.DOORs, HP ALM, Any PLM tools, Requirement management tools
Keyskills :
mechanical testinghardware testingtest case generationsoftware testingtest designing