NPD Test Lead

- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. - We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.  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. All your information will be kept confidential according to EEO guidelines.