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Requisition Number 17-0013
Post Date 10/16/2017
Title Principal Electrical Design Engineer
City Mountain View
State CA
Description
Job Summary:
• Support the development of novel electrical aerosol drug delivery technologies and devices
• Help establish and manage the device design history file (DHF) and technical file; compile required data and documentation to support regulatory submissions
• Support interdepartmental activities in device design development, design verification and validation
• Perform design tradeoff analyses, stability testing, implement design improvement cycles and conduct design cycle evaluation testing
• Develop specifications, conduct technical investigations and perform testing to ensure compliance with regulatory standards
• Select, evaluate, develop and manage outside consultants and design firms

Responsibilities:
• Design and develop analog and digital electronics and high power rechargeable battery for aerosol drug delivery devices
• Develop and implement innovative technologies for aerosolized drug delivery
• Integrate new and existing technologies to create commercially viable medical devices
• Support the development and release of firmware
• Conduct in-house prototyping, testing, failure analysis and verification of new device designs
• Analyze/document test results and maintain engineering records to GMP standards
• Coordinate and work with Nationally Recognized Test Laboratories (NRTL) to perform testing of device to regulatory safety and EMC standards
• Prepare technical engineering documentation including design requirement specifications, hardware design description, block diagrams, electrical schematics and circuit analysis, engineering drawings, specification control drawings, electrical design documents, risk analyses, DFMEA, etc.
• Create calibration requirements and specify calibration methods, equipment and processes
• Specify critical production methods, procedures, equipment and manufacturing processes Establish and manage device design history file (DHF) and technical file
• Interface with suppliers/vendors to help design and select components and materials
• Evaluate and create intellectual property
• Participate as a key member of cross-functional project teams
Requirements
Skills required:
• Hands-on electronics design of medical devices or other regulated industry
• Design of analog and digital microcontroller-based and power circuits and serial communications
• Experience with embedded software development
• Experience with high power, rechargeable battery characterization and testing
• Integration of electronics, mechanics and firmware and system characterization and validation
• Design of data acquisition systems, test fixtures and custom test equipment
• Excellent oral and written communication skills as well as strong interpersonal skills
• Well versed in Food and Drug Administration (FDA) regulations for medical devices and products, especially as it relates to building and maintaining a DHF and technical file
• Experience working in compliance with GMP regulations

Education and experience:
• BSEE or higher or an equivalent foreign degree in Electrical Engineering
• Minimum of 10 years of experience in hardware, design, electrical, or electronics engineering related to the development of high volume, consumer focused medical devices
• Aerosol drug delivery device experience is a plus
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