Lead/Senior Firmware Engineer – Sunnyvale

M2 Medical is medical device company bringing to market major advancements in the treatment of Diabetes. We are looking for a Senior/Lead Firmware Engineer who will be responsible for developing embedded firmware for an electromechanical pump system and related products. The selected candidate will be part of a team of Software Engineers developing machine control algorithms, device drivers, GUI, and interfaces to the Real Time OS for a novel medical device. This position requires the ability to specify, design, analyze, simulate, prototype, document, code, test and release to manufacturing the aforementioned software. They will define and analyze software requirements, working closely with cross functional groups including marketing, system engineering, hardware engineering, project management, quality, and regulatory. They will be responsible for coordinating technical feasibility studies and providing input into software sizing, estimating and planning activities. They will perform architectural and detailed design decisions using state of the art methodologies.Responsibilities include: Design and develop embedded systems firmware in C on microcontroller platforms using Real Time Operating Systems for medical applications. Organize, plan, track and close out design problems associated with product performance in Engineering, Manufacturing and the field. Develop specifications, architectures, designs, schedules, test plans, etc. related to product development activities and product upgrades. Perform research and development functions used in the development of new products or improvement to existing products. Propose corrective actions or changes to design, processes, or procedures when necessary. Propose and prepares design concepts and assists in the building of prototype products. Successfully plan, implement, complete, and document engineering builds. Completes all engineering documentation related to assigned projects such as plans, technical reports, project notebooks, design input, technical drawings, and manufacturing instructions. Participate in coding, reviews, and verification activities as required. Work with the Regulatory/Quality department to ensure that design and test specifications for the system meet or exceed all applicable regulatory standards, all risks are identified and mitigated to an acceptable level. Ensuring compliance with FDA, corporate standards as applicable, providing input to and participating in software process improvement activities, and providing leadership on cross-functional project problem analysis and design improvements.Requirements:MEDICAL DEVICE EXPERENCE REQUIRED! BS in Electrical Engineering, Computer Science, Computer Engineering or other physical science degree with relevant experience. Experience working in a start-up environment required Experience working at a medical device company required Minimum of five (5) years of working experience in embedded SW and HW development. Minimum of five (5) years experience developing embedded code in C/C++ Proven experience in system design and embedded development for control applications, e.g., motor control, PWM, etc. Experience with ARM/MSP based microcontrollers. Strong experience in C, and working in a multi-threaded environment is required. Working knowledge of VISIO. Must be experienced using embedded software development tools including debuggers, trace probes, oscilloscopes, and logic analyzers. Must have experience performing system level risk and software hazard analysis, FMEAs, with strong problem solving skills including the ability to determine the root cause of product problems and to propose appropriate solutions with consideration for all trade-offs in implementation. Must be a self-starter, hands on, direct and clear communicator, honest, genuine, confident and secure. Working knowledge of software development support tools such as version control, defect tracking, requirements management and system modeling tools is required. Must have excellent written and oral skills. Operational experience required with an RTOS (Real Time Operating Systems), especially a modern micro-kernel version. Development experience with battery powered systems is a plus. Knowledge of FDA and ISO quality system regulations as they apply to medical devices. Knowledge of FDAs guidance on design controls and software validation as well as ANSI/IEEE standards for software engineering.Principals Only!

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Salary: $100,000 - $135,000