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Principal Software Engineer

Company: Pave Talent
Location: San Diego
Posted on: April 10, 2021

Job Description:

As a key member of our Device Development team, the Principal Software Engineer is responsible for software activities across several projects for the development of electronics-based medical devices. Development includes process from pre-concept through architecture definition, development, verification, transfer, and product manufacturing. The primary activity is development for operation on a low power microprocessor including system-level control and management of peripherals. In support of device realization, development and manufacturing aids are also created and deployed. Further RF linked satellite devices may be employed. The successful Principal Software Engineer has strong engineering, scientific, and regulatory knowledge. This Principal Software Engineer shall work well both individually in code development and tightly with other software, electronics, and mechanical engineers in the rapid development of novel medical devices. Responsibilities of the Principal Software Engineer --- Manages Software development from pre-concept to production for compact medical devices.--- Manages code creation and development for device operating from a low power microprocessor.--- Drives software operation of device peripherals including sensors, LED elements, RF radio, motor drive, etc.--- Manages medical device software design, development, verification, and validation to FDA major level of concern.--- Works on complex issues where analysis of situation or data requires an in-depth evaluation of variable factors.--- Collaborates with Quality Team to ensure procedures and methods to ensure quality standards are met and maintained throughout the development cycle.--- Drives software project timelines and resource needs for device projects.--- Directs contribution to all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.e., 510k, De Novo 510K, and PMA). Key Qualifications of the Principal Software Engineer --- Minimum BS in SWE, EE, CE, CSE.--- A minimum of 7 years' experience in device product development, preferably in medical devices and drug/device combinations.--- Extensive experience in commercializing devices from pre-concept to production.--- Working knowledge of Medical Device Development Life Cycle and Manufacturing.--- Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485.--- Min. 5yrs 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--- Understanding of electronics components, systems, and circuit design.--- Experience programming the operation of RF radio communications.--- Document generation and practices supporting approval of software-driven medical devices.--- 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 . Rewards & Benefits --- Annual performance bonus program--- PTO--- Health, Dental, & Vision Insurance--- Flexible Spending Account (FSA)--- 401(K) Plan w/ employer contributions--- Tuition Assistance If interested, please email a resume and explain; --- Experience working with Medical Devices or Drug Devices?--- Experience with firmware development in C/C++/assembly? Pave Talent is an Equal Opportunity Employer.

Keywords: Pave Talent, San Diego , Principal Software Engineer, IT / Software / Systems , San Diego, California

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