Principal Software Engineer(firmware development in C/C++/assembly & medical devices)
Full Time
San Diego, CA
Posted
Job description
Requirement:
- Minimum BS in SWE, EE, CE, CSE.
- A minimum of 10 years’ experience in device product development, preferably in medical devices and drug/device combinations.
- Extensive experience in commercializing devices from pre-concept to production.
- Good Project Management skills.
- Working knowledge of Medical Device Development Life Cycle and Manufacturing.
- Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485.
- Familiarity with IEC 62304 Min. 7yrs firmware development in C/C++/assembly.
- Strong knowledge of I2C, SPI, UART, BLE protocols and driver development.
- Experience working STM 32-bit Cortex M-processors or similar.
- Strong object-oriented programming and design skills.
- Understanding of electronics components, systems and circuit design.
- Experience programming the operation of RF radio communications.
- Experience in configuring and managing a software revision control.
- Document generation and practices supporting approval of software driven medical devices.
- Strong mathematical skills and understanding of data information processing methods for real time algorithm deployment on portable equipment.
- Experience in writing control software (C#/Python) for custom test equipment supporting novel device development.
- Familiarity with domestic and international regulations and industrial guidance documents (e.g., ISO, FDA guidance and CE Mark requirements).
- Knowledge of Eclipse, TrueSTUDIO (Atollic) or similar IDEs.
- Ability to handle multiple project and priorities with exceptional organizational and time management skills.
- Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate to people at all levels of the organization and lead with influence.
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