Medical Devices Firmware Architect

4 weeks ago

Chennai, India Quest Global Full time

We are also Considering candidates Willing to Relocate - Job Location : Chennai


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

Experience : 15 - 25 Years


We are accepting Job Applications :

Please submit updated CV - Email : ;


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


Senior / Firmware Architect - Medical Devices | 10 - 20 Years |


Job Description

Responsibilities include

- Design and architect embedded software systems from concept to production.

- Lead and mentor a team of embedded software engineers.

- Develop and maintain embedded software architectures and design patterns.

- Optimize software for performance, reliability, and power consumption.

- Conduct code reviews and ensure compliance with industry standards and best practices.

- Interface with hardware engineers to define system requirements and specifications.

- Develop and execute testing and validation plans for embedded software.

- Stay updated with the latest advancements in embedded systems and incorporate relevant technologies.

- Document software design and development processes.

- Guide and provide necessary support for embedded software development according to medical device compliance and regulations(FDA, EU-MDR primarily).

- Adaptive to manage and co-ordinate cross functional demand during product development and maintenance.


Skills & Qualifications

- Bachelor's or Master’s degree in Computer Science, Software Engineering, Electronics Engineering, or a related field.

- Embedded architect experience primarily medical device. (High preference for hemodialysis machine and Renal care device experience)

- Knowledge in IEC 62304, IEC 60601, ISO 13485 based embedded development.

- Medical devices experience who can write SRS and run the entire product design process.

- Over 12 years of experience in embedded software development and architecture.

- Proficiency in Embedded firmware using embedded C, C++, and assembly languages.

- Extensive experience with real-time operating systems (RTOS) and embedded Linux.

- Strong knowledge of microcontroller/microprocessor architectures.

- Experience with communication protocols such as CAN, I2C, SPI, UART, USB, etc.

- Excellent problem-solving and debugging skills.

- Proven track record of leading and managing engineering teams.

- Strong communication and documentation skills.

- Professional certifications in embedded systems or software architecture are a plus.


Preferred Skills:

- Experience with hardware design and schematic review.

- Knowledge of modern software development methodologies (Agile, Scrum).

- Familiarity with version control systems such as Git.

- Understanding of safety-critical systems and compliance standards.


Differentiators

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

o Strong experience in Renal Care

o Usability Analysis

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