Medical Devices Firmware Architect

• Design and architect embedded software systems from concept to production.
• Conduct code reviews and ensure compliance with industry standards and best practices.
• Lead and mentor a team of embedded software engineers.
• Stay updated with the latest advancements in embedded systems and incorporate relevant technologies.
• Guide and provide necessary support for embedded software development according to medical device compliance and regulations(FDA, EU-MDR primarily).
• Interface with hardware engineers to define system requirements and specifications.
• Develop and execute testing and validation plans for embedded software.
• Document software design and development processes.
• Develop and maintain embedded software architectures and design patterns.
• Optimize software for performance, reliability, and power consumption.

• Strong knowledge of microcontroller/microprocessor architectures.
• Medical devices experience who can write SRS and run the entire product design process.
• Experience with communication protocols such as CAN, I2C, SPI, UART, USB, etc.
• Strong communication and documentation skills.
• Extensive experience with real-time operating systems (RTOS) and embedded Linux.
• Over 12 years of experience in embedded software development and architecture.

Experience : 15 - 25 Years

• Excellent problem-solving and debugging skills.

Embedded Firmware Architect | Medical Devices | IEC 62304, IEC 60601 |

o Strong experience in Renal Care

o Experience in New Product Development(NPD) of medical devices.

• Proficiency in Embedded firmware using embedded C, C++, and assembly languages.
• Professional certifications in embedded systems or software architecture are a plus.
• Knowledge in IEC 62304, IEC 60601, ISO 13485 based embedded development.
• Experience with hardware design and schematic review.
• Knowledge of modern software development methodologies (Agile, Scrum).
• Embedded architect experience primarily medical device. (High preference for hemodialysis machine and Renal care device experience)
• Bachelor's or Master’s degree in Computer Science, Software Engineering, Electronics Engineering, or a related field.
• Adaptive to manage and co-ordinate cross functional demand during product development and maintenance.
• Familiarity with version control systems such as Git.
• Understanding of safety-critical systems and compliance standards.
• Proven track record of leading and managing engineering teams.

o Usability Analysis