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Embedded Test Lead (Burlington)

Embedded Test Lead (Burlington)

YochanaBurlington, MA, US
9 hours ago
Job type
  • Part-time
Job description

Note- 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 :

  • Bachelors or Masters 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.
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    Test Lead • Burlington, MA, US