Principal Embedded Engineer - Direct Hire

Ready for the next step in your career? Leading medical devices is looking for a Principal Embedded Engineer in Waltham, MA. This is a direct hire opportunity!

Responsibilities of the Principal Embedded Engineer:

• Collaboratively work with System's Engineering to translate system-level requirements into product architectures making tradeoff decisions regarding hardware and software partitioning
• Uses modeling, hardware-in-the-loop simulation, and actual devices to develop, debug, and test complex systems to meet the required performance
• Develop software subsystem architectures aligned to product-level requirements and architectures including software requirements definitions and sub-system designs
• Design and develop software/firmware utilizing C and C++ on embedded real-time operating systems (RTOS) following company and industry requirements and best practices
• Performs advanced risk analyses using FMEA and fault tree methods. Works with other engineering disciplines to develop, implement, and verify solutions
• Perform software verification including code reviews, writing unit test cases, and running static analysis

Qualifications of the Principal Embedded Engineer:

• Bachelor's degree in software or electrical engineering. Master's degree preferred.
• 10+ years of Software Engineering experience in the design and development of complex, software-driven electromechanical Class II medical devices; Class III experience preferred
• Detailed knowledge of key regulatory requirements included ISO 13485, ISO 14971, ISO 62304 as well as FDA QSR 21 CFR Part 820C
• Experience with electronic design control and document management systems preferred

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