Katalyst CRO
Overview
NPD Test Lead role at Katalyst CRO. Lead end-to-end NPI activities for embedded software testing in medical devices and ensure compliance with regulatory standards. 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. Requirements
Bachelor's or master's degree in computer science, Electronics, Biomedical Engineering, or related field. 12+ years of experience in embedded software development and testing for medical devices. Experience with Appium or any other mobile test automation framework. Strong understanding of IEC 62304, FDA regulations, and SaMD standards. Hands-on experience 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. Experience with cybersecurity standards for medical devices. 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
Quality Assurance Industries
Pharmaceutical Manufacturing
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NPD Test Lead role at Katalyst CRO. Lead end-to-end NPI activities for embedded software testing in medical devices and ensure compliance with regulatory standards. 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. Requirements
Bachelor's or master's degree in computer science, Electronics, Biomedical Engineering, or related field. 12+ years of experience in embedded software development and testing for medical devices. Experience with Appium or any other mobile test automation framework. Strong understanding of IEC 62304, FDA regulations, and SaMD standards. Hands-on experience 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. Experience with cybersecurity standards for medical devices. 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
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr