NPD Test Lead

KatalystHealthcaresLifeSciences

Burlington, MA, United States contract

Posted: July 28, 2025

Job 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.

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.

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