AI Technologies LLC.
Overview
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. 1 2 + 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, UARTcommunication 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. AI TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. AI TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will AI TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract
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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. 1 2 + 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, UARTcommunication 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. AI TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. AI TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will AI TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract
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