NPD Test Lead

Katalyst Healthcares & Life Sciences; Burlington (MA); On-site; USD 105,000 - 135,000; Full time

Job summary

Katalyst Healthcares & Life Sciences is seeking an experienced professional for embedded software testing in medical devices. You will lead NPI activities, ensuring compliance with FDA guidelines and managing communication protocols. Ideal candidates should have over 12 years of experience in the field and a relevant degree.

This role requires strong leadership skills, a thorough understanding of relevant regulations, and hands-on experience with multiple communication protocols. Join us to contribute significantly to our mission in clinical research.

Qualifications

• 12+ years of experience in embedded software development and testing for medical devices.
• Strong understanding of IEC 62304 and SaMD standards.
• Proven experience managing offshore and onsite teams.

Responsibilities

• Lead end-to-end NPI activities for embedded software testing.
• Manage and troubleshoot communication protocols like BLE, Serial, SPI, UART.
• Ensure compliance with FDA guidelines and SaMD testing protocols.

Skills

Embedded software testing

BLE communication

Leadership

FDA regulations

Problem-solving skills

Education

Bachelor's or master's degree in computer science, Electronics, Biomedical Engineering

Tools

Appium

Protocol sniffers

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.

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.