Firmware Test & Verification R&D Engineer (Medical Device/ Regulatory Requirements)

Responsibilities:

• Development of test firmware and performing firmware verification of new products for medical and other mission-critical systems.
• Design and develop test firmware to realize new solutions with assuming overall responsibility for the delivery and quality of the new solutions
• Improving the firmware/software development and verification process. Establish automated testing process and tools.
• Review & revise primary documentation of components and systems according to relevant FDA, GMP, ISO and IEC standards.
• Oversee the continuous improvement in the design verification and validation processes to keep pace with changes in the regulatory environment.

• Bachelor's degree in Software Engineering, Electronics Engineering, Computer Engineering or Computer Science with 3 years of relevant experience in firmware verification and validation of medical devices.
• In-depth knowledge of complex embedded software/firmware development on Linux, RTOS or embedded Windows platform
• Good awareness of emerging technologies and trends in the embedded software industry
• In-depth knowledge of test and design verification methodologies, required documentations, and regulatory requirements
• Experience in bringing new medical device/equipment through the verification and validation process to market introduction,
• Knowledge of industrial manufacturing procedures
• Good analytical and troubleshooting skills with a creative mindset.
• Good awareness of emerging trends in the medical device regulatory environment, and good knowledge of general and medical device/equipment regulatory standards & requirements.