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Job Description

Job Summary :


We are seeking an experienced Embedded Software Engineer with strong expertise in C/C++ embedded development and medical device software standards. The ideal candidate will work on safety-critical embedded systems, contributing across the full software development lifecycle in compliance with global medical device regulations.


Key Responsibilities :


- Design, develop, and maintain embedded software using C and C++ for medical devices.


- Work with microcontrollers such as STM32 and ARM Cortex families.


- Develop and integrate software on Linux, RTOS, and embOS RTOS platforms.


- Implement and execute unit testing using frameworks like GTest or Unity.


- Perform software debugging using industry-standard debugging and analysis tools.


- Follow and contribute to the medical device software lifecycle in compliance with IEC 62304.


- Prepare and maintain DHF documentation, including :

  • Software requirements
  • Architecture and detailed design
  • Verification and validation
  • Risk management artifacts

- Ensure compliance with ISO 13485, FDA regulations, and relevant ISO standards.


- Maintain software traceability using documentation and traceability management tools.


- Collaborate closely with hardware, QA, regulatory, and system engineering teams.


- Participate in design reviews, code reviews, and audits.


- Use version control systems (Git) for source code management.


Required Skills & Qualifications :


- Strong experience in embedded software development using C and C++.


- Hands-on experience with Linux, RTOS, and embOS RTOS.


- Expertise in STM32, ARM Cortex microcontrollers.


- Experience with unit testing frameworks such as GTest or Unity.


- Proficiency in debugging tools, compilers, and IDEs.


- Strong understanding of IEC 62304 medical device software lifecycle.


- In-depth knowledge of ISO 13485 quality management systems.


- Familiarity with Design History File (DHF) components.


- Knowledge of FDA regulations and medical device compliance standards.


- Experience with documentation and traceability tools.


- Excellent written and verbal communication skills.


- mad skill-knowledge of medical device software lifecycle standards (IEC 62304).


- In-depth knowledge of ISO 13485


Preferred / Good to Have :


- Experience working on regulated, safety-critical systems.


- Exposure to risk management standards such as ISO 14971.


- Experience supporting regulatory audits and inspections.


- Knowledge of CI/CD practices for embedded systems.


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