Hardware Development Engineer - Job Code H14LI at eNeura, Inc. in San Francisco Bay Area - Job

Hardware Development Engineer - Job Code H14LI at eNeura, Inc. in San Francisco Bay Area - Job | LinkedIn

Job description

We are seeking a full-time Hardware Development Engineer to collaborate with other Engineering, Manufacturing and Marketing staff to design, develop, test and launch transcranial magnetic stimulation (TMS) products that satisfy market specifications and end-user requirements. Conduct these activities according to ISO & IEC 60601-x compliant standards and to FDA medical device product development processes. You will be a part of an interdisciplinary design and development team.

RESPONSIBILITIES

• Prepare and review functional requirements, technical specifications and other design documents, in accordance with cGMP guidelines. Understand and communicate to others how such functional requirements and technical specifications impact product design.
• Translate functional requirements and specifications into working circuits and subsystems using knowledge and principles of electrical engineering, programmable logic and contemporary embedded microcontrollers.
• Design, develop and debug digital circuits that meet a product's functional requirements and technical specifications in presence of high EMI. Digital circuits may include: microcontrollers, flash memory, SPI-I2C-UART-USB serial interfaces, realtime clock, FPGAs and display interfaces.
• Design, develop and debug moderate-frequency analog circuits that meet a product's functional requirements and technical specifications in presence of high EMI. Analog circuits may include: OpAmp signal conditioning, filters, low-voltage switching & LDO power regulators, load switches and SCR trigger circuits. High-voltage low-current power supplies up to 1000 VDC.
• Survey, identify and select suitable components that meet the design requirements. Identify and interact with vendors, as required, to procure samples and evaluation kits.
• Capture designs using electrical schematic and block diagram CAD tools. Develop and evaluate designs using pSPICE or equivalent circuit simulation CAD tools.
• Coordinate with subcontractors to layout PC boards and with our Contract Manufacturer to produce design first articles for test and debug.
• Assemble, build and bench-test breadboards and design-prototypes. Work with hand tools, SMT solder stations, power supplies, multimeters, oscilloscopes, function generators, current probes, signal analyzers, in-circuit programmers, and other basic test instruments.
• Plan and run lab tests to characterize electrical and environmental performance of breadboards, design-prototypes, first article PCBs and systems by collecting and analyzing measured data.
• Conduct failure mode investigations (FMEA), and risk analysis of medical devices according to FDA QSR. 
• Coordinate with external test labs to conduct electromagnetic compliance and environmental testing.
• Provide necessary documentation to support design history files (DHF's). Assist with hardware design verification and product validation efforts.
• Apply engineering skills in a collaborative team to assist with sustaining engineering tasks for released products as required.

Desired Skills and Experience

KNOWLEDGE, TRAINING and SKILLS

• Results oriented self-starter. Ability to prioritize tasks and work independently.
• Strong interpersonal and collaborative skills. Able to interface with functional groups outside of engineering.
• Good communication skills, verbal and written.
• Experience with computer aided design, simulation and optimization tools (Cadence/OrCAD schematic capture, pSPICE, or equivalents).
• Experienced with PC Board layout tools, is desirable (Allegro or equivalent).
• Experience using personal computer tools for text editing/word processing and spreadsheets (Microsoft Word and EXCEL preferred)

ADDITIONAL DESIRED KNOWLEDGE

• Experience designing electromagnetic components is desirable (rotating machinery, solenoid actuators, etc).
• Experience with Infolytica MagNet, ANSYS Maxwell or equivalent tool.
• Experience using SolidWorks mechanical CAD tool is desirable.
• Experience programming with National Instruments LabView lab-automation tools is desirable.

EXPERIENCE

Minimum 10-15 years of experience developing patient care, and minimum 5-7 years developing medical electronic devices. Experience developing devices according to FDA and IEC 60601-1 standards desirable.

EDUCATION

Bachelor's Degree in Electrical Engineering, Masters or equivalent preferred.