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NPD Test Lead

NPD Test Lead

Katalyst Healthcares & Life SciencesBurlington, MA, US
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Job Description

Job Description

Company Description

  • 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.

Job Description

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.

    • Additional Information

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

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    Test Lead • Burlington, MA, US

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