Mandatory :
- Hands experience in Verification of Software 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.
- Must have hands on experience in writing Verification plan, verification protocols, testing and generating Verification test results / reports.
- Have hands on experience on standards like IEC60601-1-8, review the applicable requirements and hands experience in execute pre-compliance and formal complicable tests with internal team and external labs.
- Have good knowledge on Software Development life cycle process as per IEC 62304 and ISO 14971
- Identify issues from verification, log the issues in tools like JIRA or ClearQuest, Drive defect control board, review with cross functional team and verify the resolutions.
- Must have experience in verification of Embedded firmware / software.
- Have Experience in Software reliability demonstration and Automation testing.
- Have collaboration with Internal team and external team to bring best practices.
- 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 toolsPreferred Companies / Industries :
Health care or Medical equipment - Verification & ValidationSkills Required
Jira, Clearquest, plm tools , Verification, Software Development Lifecycle, Testing