Work from Office
Full Time
Role & responsibilities Must to Have - - Hands-on experience on Medical electronics devices of Class IIa/ IIb or Class III - 5 to 8 years of practical experience on end-to-end embedded product development lifecycle and specific focus on Verification and Validation of Software as well as Hardware for different Medical Systems - Good in Analyzing, assessing and understanding in-depth of System as well as Sub-system requirements, from V&V feasibility perspective and to gain the required knowledge in advance - Must have hands on experience in end -to-end testing life cycle of embedded medical electronic devices (i.e. System testing, Sub-system testing etc.) - Must have hands on experience in writing Verification plan, verification protocols, Test execution and generating Verification test results/reports. - Must have proven experience in designing the protocols and review all V&V documentation with eye for details and maintaining overall good documentation practices and adhere to the QMS to ensure and prove the Quality processes are implemented, followed and are in practices throughout the project lifecycle. - Must be a good team player and able to provide the guidance to the team on embedded medical systems testing. Good to have - - Have hands on experience on requirement analysis and assessment based on standards like IEC60601-1, review the applicable requirements and hands-on experience in executing pre-compliance and compliance tests complying to the product Environmental testing, EMI, EMC and Safety standards. - Proven experience on the Computer System Validation of the SW as well as HW tools as a part of tool validation. - Have good knowledge and experience on Software Development life cycle process as per IEC 62304 and Risk Management as per ISO 14971 - Identify issues from verification, log the issues in tools like JIRA or any other test management and defect management tool, Drive defect control board, review with crossfunctional team and verify the resolutions. - Must have experience in verification of Embedded firmware and 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 Endoscopy or any hardware products with digital content from medical devices domain will be an advantage.
Capgemini
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