Description
Position Summary
Our client, a leader in the medical device industry, is seeking a highly skilled Facilities Software Engineer to join their team. This individual will provide software and firmware design, development, and validation for innovative medical devices and equipment. The Facilities Software Engineer will take ownership of software system architecture design while contributing across the full software development lifecycle—including requirements definition, risk analysis, implementation, code reviews, and testing. The ideal candidate will bring strong embedded development expertise, regulatory knowledge, and a passion for delivering safe, reliable, and compliant medical technology.
Key Responsibilities
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Lead the technical aspects of software development on assigned projects.
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Participate in the evaluation and selection of system architectures and technologies.
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Conceive, document, and develop software architectures.
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Author software development plans, requirements specifications, and risk assessments.
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Design, code, and implement software for medical devices in compliance with IEC 62304.
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Prepare and maintain comprehensive design history documentation.
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Develop and execute unit testing, verification, and software characterization testing.
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Contribute to product validation activities, including code reviews, validation protocols, and test reports.
Other duties as assigned. Responsibilities may change at any time with or without notice.
Required Skills & Abilities
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Strong experience in sensor data acquisition and processing, motor controls, temperature controls, bootloader design, networking, GUI/touchscreen, and device driver development.
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Proficiency with communication buses (I2C, SPI, RS232, 1-wire) and Ethernet protocols.
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Demonstrated experience with embedded microprocessor software/firmware development (ARM-based, DSP, and mixed-signal microcontrollers).
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Familiarity with IEC 62304 software quality standards; understanding of FDA QSR principles preferred.
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Self-motivated, able to work independently with minimal supervision.
Education & Experience
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8+ years of software development experience with C, C++.
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2+ years with C#, GUI implementations, and Python.
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8+ years of embedded firmware development and debugging.
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B.S. in Software Engineering, Electrical Engineering, or related field required.
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M.S. degree preferred.
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Prior experience in the medical device industry highly desirable.