Embedded Tester

Cloud Hybrid Technologies, LLC; Burlington (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Cloud Hybrid Technologies, LLC is seeking an embedded software test engineer to lead end-to-end NPI testing for medical devices. The role emphasizes IEC 62304 compliance, SaMD testing, and collaboration across onsite and offshore teams. Strong communication and leadership are essential.

Required experience includes 1–2+ years in embedded testing and familiarity with Appium and protocol sniffers. Location is in Massachusetts with a full-time on-site workload and regulatory interaction

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Electronics, Biomedical Engineering, or related field.
• 1–2+ years of experience in embedded software testing for medical devices is required.
• Experience with Appium or any mobile test automation framework.
• Strong understanding of IEC 62304, FDA regulations, and SaMD standards.
• Familiarity with BLE, Serial, SPI, UART communication protocols.

Responsibilities

• Lead end-to-end NPI activities for embedded software testing in medical devices.
• Oversee test protocols, strategy and automation aligned with IEC 62304 standards.
• Manage communication protocols including BLE, Serial, SPI, UART.
• Use protocol sniffers and debugging tools to resolve issues.
• Ensure compliance with FDA guidelines, SaMD testing protocols and regulatory standards.
• Collaborate with onsite and offshore teams to resolve challenges.
• Drive STLC processes and ensure QA quality.
• Interface with regulatory bodies and support audits and submissions.
• Communicate effectively with engineering, QA, regulatory, and product teams.

Skills

Embedded testing

Test automation

Communication

Leadership

Problem solving

Offshore/on-site management

Education

Bachelor’s or Master’s in CS/EE/Biomedical Eng

Tools

Appium

Protocol sniffers

Debugging tools

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.

Required Qualifications

• Bachelor’s or Master’s degree in Computer Science, Electronics, Biomedical Engineering, or related field.
• 1 2 + years of experience in embedded software testing for medical devices.
• Experience with Appium or any other mobile test automation framework.
• Strong understanding of IEC 62304, FDA regulations, and SaMD standards.
• Knowledge 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.

Preferred Qualifications

• Knowledge of ISO 14971, ISO 13485, and other relevant standards.

Cloud Hybrid is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. Cloud Hybrid will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will Cloud Hybrid require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract.