Software Test Engineer

Job Title: Software Test Engineer

Location: Cambridge, MA (100% Onsite)

Job Type: 6+ Months Contract-to-Hire (FTE conversion potential) Visa: Open to all visa types Experience Required: Minimum 5 years

Overview:

We are seeking an experienced Software Test Engineer with a strong background in medical device testing , embedded systems, and regulatory compliance. The ideal candidate will be responsible for validating embedded and distributed systems in a regulated FDA environment , ensuring compliance with IEC 62304 and 21 CFR Part 820 .

Must-Have Qualifications:

Minimum 5 years of experience in software testing roles

Medical Device industry background

Proficient in Linux and Microsoft Windows OS

Strong experience with embedded device testing

Working knowledge of FDA regulations : IEC 62304, 21 CFR Part 820

Hands-on experience in real-time, large-scale distributed client-server applications

Proficient with network protocols (TCP/IP) and Cisco equipment/configuration

Experience with wireless technologies (802.11) and RF testing

Scripting skills using Python

Experience automating tests using C#

Familiarity with network traffic analysis tools (wired and wireless)

Exposure to virtualization platforms like VMware and Hyper-V

Working knowledge of Agile testing methodologies

Experience with HL7 and medical device interoperability

Highly Preferred:

Local to Cambridge, MA

Prior experience at Philips or similar medical device companies

Key Responsibilities:

Design and execute detailed test plans and test cases for embedded and distributed systems

Develop and maintain automated test suites

Participate in regression, functional, system, and integration testing

Collaborate with developers and systems engineers to troubleshoot and resolve defects

Ensure all test activities are conducted in compliance with FDA and ISO standards

Document and report test results to stakeholders

Assist in risk analysis and verification/validation processes

Nice to Have:

Experience with test management tools (e.g., JIRA, Zephyr)

Familiarity with CI/CD pipelines

Knowledge of cybersecurity protocols in medical devices