Yochana
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Need to have device testing experience in Medical Device Domain Key Responsibilities
Lead end-to-end NPI activities for embedded software testing in medical devices. Oversee Test protocols, test strategy and test automation testing aligned with
IEC 62304
standards. Manage and troubleshoot communication protocols including
BLE, Serial, SPI, UART . Utilize protocol sniffers and debugging tools to resolve technical issues. Ensure compliance with
FDA guidelines ,
SaMD
testing protocols, and other regulatory standards. Collaborate with cross-functional teams across onsite and offshore locations to resolve technical challenges. Drive
Software Testing Life Cycle (STLC)
processes and ensure quality assurance. Interface with regulatory bodies and support documentation for audits and submissions. Communicate effectively with stakeholders, including engineering, QA, regulatory, and product teams. Required Qualifications
Bachelor’s or Master’s degree in Computer Science, Electronics, Biomedical Engineering, or related field. 12+ years of experience in embedded software testing for medical devices Experience with Appium or any other mobile test automation framework Strong understanding of
IEC 62304 ,
FDA regulations , and
SaMD
standards. Knowledge with
BLE , Serial, SPI, UART communication protocols. Proficiency in using
protocol sniffers
and debugging tools. Proven experience managing
offshore and onsite teams . Excellent communication, leadership, and problem-solving skills. Familiarity with
STLC , risk management, and design controls. Preferred Qualifications
Knowledge of ISO 14971, ISO 13485, and other relevant standards. PMP or similar certification is a plus. Seniority level
Mid-Senior level Employment type
Contract Job function
Health Care Provider, Quality Assurance, and Engineering Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Need to have device testing experience in Medical Device Domain Key Responsibilities
Lead end-to-end NPI activities for embedded software testing in medical devices. Oversee Test protocols, test strategy and test automation testing aligned with
IEC 62304
standards. Manage and troubleshoot communication protocols including
BLE, Serial, SPI, UART . Utilize protocol sniffers and debugging tools to resolve technical issues. Ensure compliance with
FDA guidelines ,
SaMD
testing protocols, and other regulatory standards. Collaborate with cross-functional teams across onsite and offshore locations to resolve technical challenges. Drive
Software Testing Life Cycle (STLC)
processes and ensure quality assurance. Interface with regulatory bodies and support documentation for audits and submissions. Communicate effectively with stakeholders, including engineering, QA, regulatory, and product teams. Required Qualifications
Bachelor’s or Master’s degree in Computer Science, Electronics, Biomedical Engineering, or related field. 12+ years of experience in embedded software testing for medical devices Experience with Appium or any other mobile test automation framework Strong understanding of
IEC 62304 ,
FDA regulations , and
SaMD
standards. Knowledge with
BLE , Serial, SPI, UART communication protocols. Proficiency in using
protocol sniffers
and debugging tools. Proven experience managing
offshore and onsite teams . Excellent communication, leadership, and problem-solving skills. Familiarity with
STLC , risk management, and design controls. Preferred Qualifications
Knowledge of ISO 14971, ISO 13485, and other relevant standards. PMP or similar certification is a plus. Seniority level
Mid-Senior level Employment type
Contract Job function
Health Care Provider, Quality Assurance, and Engineering Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr