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
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