Medical Product Development - Embedded

I am seeking an experienced developer to assist me in the finalization of the design for my medical product, which is intended for treatment purposes. The ideal candidate should have expertise in working with microcontrollers for embedded systems. Key requirements for the project include: - Finalizing the design of the medical product - Developing the embedded system using a microcontroller - Ensuring the product is user-friendly and easy to operate - Conducting rigorous testing to ensure the product meets all safety and quality standards - Providing ongoing support and maintenance for the product post-launch The successful candidate should have: - Extensive experience in developing embedded systems using microcontrollers - A deep understanding of the medical product development process - Strong problem-solving skills and attention to detail - Excellent communication skills and the ability to work collaboratively with a team Job Responsibilities • Embedded Systems Design: You would be responsible for designing and developing embedded systems for medical devices. This includes selecting appropriate hardware components, designing the system architecture, and implementing the software/firmware that controls the device's functionality. • Firmware Development: You would write and debug low-level firmware code that runs on microcontrollers or other embedded systems. This code would be responsible for controlling the device's operations, including data acquisition, signal processing, user interfaces, and communication protocols. • Hardware Integration: You would work closely with hardware engineers to integrate the firmware with the electronic components and sensors used in the medical device. This involves designing and testing the interfaces, ensuring proper signal conditioning, and collaborating on PCB layout and circuit design. • Verification and Validation: You would be responsible for testing and verifying the functionality, performance, and safety of the embedded systems. This includes creating test plans, conducting tests, analyzing the results, and documenting the findings to ensure compliance with regulatory standards and quality guidelines. • Regulatory Compliance: Medical devices are subject to strict regulations and standards, such as ISO 13485 and FDA guidelines. You would need to ensure that the embedded systems meet these requirements, including documentation, risk analysis, and participating in regulatory submissions. • Collaboration: You would collaborate with cross-functional teams, including software engineers, mechanical engineers, and biomedical engineers, to ensure seamless integration of the embedded system with the overall medical device design. Effective communication and teamwork are crucial for successful product development. • Troubleshooting and Debugging: You would be responsible for identifying and resolving issues in the embedded systems during the development process or in post-production stages. This involves analyzing and debugging software/firmware problems, working with hardware engineers to diagnose hardware-related issues, and implementing appropriate solutions. • Documentation: You would create and maintain accurate and detailed documentation throughout the development process. This includes design specifications, test plans, technical reports, and user manuals to ensure traceability, reproducibility, and regulatory compliance. • Continuous Learning: You would stay up to date with the latest advancements in embedded systems, medical device regulations, and related technologies. This could involve attending conferences, participating in training programs, and conducting research to enhance your knowledge and skills. If you have the skills and experience needed to help bring my medical product to market, please submit your proposal.