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Job Location | Bangalore |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | IT - Software |
Functional Area | General / Other Software |
EmploymentType | Full-time |
Minimum Qualifications B.E. from reputed university in Computer Science; Electronics; Biomedical; InstrumentationEngineering 4+ years in product development of complex electro-mechanical devices controlled by SW; with3+ years in testing roles Knowledge of medical device quality and regulatory standards (ISO 13485; ISO 14791; IEC60601; IEC 62304; etc.) Strong written and verbal communication skills; with attention to detail and thoroughness Able to work in direct; cross-functional and cross-cultural teams; with strong influencing skills Able to participate in late evening and/or early morning calls Self-starter; strong work ethic and initiative in accomplishing objectives; and delivering inambiguous environmentsJob Responsibilities Create and review test protocols for verifying and validating software and system requirements Establish system validation plan; Develop test method protocols; Execute tests / produce testresult documentation / review test results for system testing and pre-clinical evaluation as perthe applicable regulatory standards. Participate/Lead risk assessments and develop mitigation plans to ensure safe operation of theproduct Participate in strategic discussions and own the technology development for the futuregeneration of the product,
Keyskills :
technology developmentsciencesystem testingenvironmental impact assessmentsoftwareiec 62304protocolsisorisktestingtestsstrategyregulatoryiecmedical