NPI Test Lead – Embedded Medical Devices & SaMD

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 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.