Katalysthealthcareslifesciences

NPD Test Lead

Burlington, MA, United States · Junior

Sponsorship not specifiedDetected 359 days ago
CybersecurityEmbedded SystemsAppiumTest AutomationClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceMedical DevicesResearchLeadershipCommunicationProblem Solving

About the role

  • All your information will be kept confidential according to EEO guidelines.

Responsibilities

  • Manage and troubleshoot communication protocols including BLE, Serial, SPI, UART.
  • Drive Software Testing Life Cycle (STLC) processes and ensure quality assurance.
  • Interface with regulatory bodies and support documentation for audits and submissions.

Requirements

  • Bachelor's or master's degree in computer science, Electronics, Biomedical Engineering, or related field.
  • 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.
  • Knowledge of ISO 14971, ISO 13485, and other relevant standards.

Nice to have

  • PMP or similar certification is a plus.

Benefits

  • Lead end-to-end NPI activities for embedded software testing in medical devices.
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