About the role
Title: Medical Device Software V&V / Unit Testing Engineer
Location: Massachusetts – Hybrid/Remote (First week onsite in MA and approximately one additional week onsite for unit testing)
Duration: Immediate start through September, with potential extension through year-end or February
Work Arrangement: Primarily remote after required onsite activities
Position Overview:
We are seeking a Medical Device Software Verification & Validation Engineer to support a short-term project involving software specifications, validation documentation, and white-box unit testing of safety-critical medical device software.
The ideal candidate will have hands-on experience testing and validating complex, mission-critical software used in medical devices, particularly software involving interlinked embedded systems, state machines, and operating system-level interactions. The software may have the potential to impact patient safety; therefore, experience with regulated medical device software development and risk management is highly valued.
The successful candidate will be comfortable working with C#, Visual Studio, software specifications, unit testing, and software validation documentation in a regulated medical device environment.
Key Responsibilities:
Perform white-box unit testing of complex medical device software.
Develop, execute, and document unit tests using C# and Visual Studio.
Analyze software requirements, internal specifications, and design documentation.
Review software architecture and understand interactions between interconnected embedded systems.
Evaluate software behavior involving complex state machines and system-level interactions.
Support software verification and validation activities for safety-critical medical device software.
Create, review, and maintain detailed software test and validation documentation.
Document test results, defects, deviations, and verification evidence.
Support traceability between software requirements, specifications, risks, and test cases.
Work with cross-functional software, systems, quality, and regulatory teams.
Apply current FDA expectations and industry best practices related to medical device software development and risk management.
Required Qualifications:
Experience in medical device software verification, validation, testing, or software quality engineering.
Hands-on experience with C# and Visual Studio.
Strong experience performing white-box unit testing.
Experience working with complex software systems involving:
Embedded systems
State machines
Interlinked software/hardware systems
Operating system-level interactions
Safety-critical or mission-critical software
Strong technical documentation and specification review experience.
Experience working in a regulated medical device environment.
Understanding of software development and software verification processes.
Highly Preferred Qualifications:
Experience with IEC 62304, particularly Class C medical device software.
Experience with ISO 14971 and software risk management.
Experience with FDA guidance related to medical device software development and software validation.
Experience with PMA products or other high-risk medical devices.
Experience with software hazard analysis, risk controls, and safety-related software requirements.
Experience with embedded medical device software.
Experience with real-time operating systems (RTOS).
Experience with complex state machines and software architecture.
Experience in software verification for systems where software failure could potentially result in patient harm.
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