Overview
Skills
Job Details
Burlington MA
Job Description:
>> 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.