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About the role
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
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