Job Description

A Day in the Life .Work with global R&D teams to develop software for new and existing medical device products. .Performs the SOUP (Software of Unknown Provenance) analysis - Responsible for timely analysis of each SOUP item identified in the Medical Device software. .Collecting Known Anomalies (KAs) and Known Cybersecurity Vulnerabilities (KVs) and analyzing the impact on the Medical Device Software. .Working with cros functional development teams to obtain Hazard IDs and Software Failure Mode Effect Analysis. .Software design and development of embedded real-time systems, including the development of Software Unit Test & Integration plans and protocols. .Participates in reviews, code inspections and will support the development of documentation required for FDA device approval. .Work effectively within a geographically dispersed and cross-functional teams during all phases of the product development process. .Develop test automation framework and test scripts. .Must be responsive, flexible, self-motivated and able to succeed within an open collaborative peer environment .Is highly effective, agile and thrives in a dynamic environment with multiple, changing priorities .Is comfortable with proactive outward communication and never shies away from a challenge. Be Agile and effectively navigate through changing project priorities. Must Have Minimum Qualification A Bachelor\'s degree in Computer science, Electrical, Electronics / equivalent from reputed institution. .7 to 10 years\' experience in Embedded Software development with at least two (2) years\' experience in the Medical device/Medical IT or regulated industry. .Experience in SOUP (Software of Unknown Provenance) analysis. .Strong experience in Software design and development for Embedded Real-Time systems development using C++ and Object-Oriented concepts. .RTOS experience with multi-threading, IPC knowledge. .Experience working in a structured software development environment following a well-defined software development process like Agile / Lean. .Experience with software risk analysis (per ISO 14971) including software failure mode and effects analysis (FMEA). Nice to Haves .Strong analytical skills. Ability to handle competing priorities, agile and maintain high energy.

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