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Requisition Number 17-0013
Post Date 7/6/2017
Title Sr Electrical/Systems Engineer
City Mountain View
State CA
Description Job Summary:
• Support development of novel electrical aerosol drug delivery device
• Help establish and manage device design history file (DHF) and technical file; ensure contents are adequate to support regulatory submissions
• Support interdepartmental activities with respect to device design development, design verification/validation, stability testing, design cycle and verification testing, specification development, investigations, testing to regulatory standards, etc.

Responsibilities:
• Support design development and documentation of test analog and digital electronics for drug delivery devices
• Conduct in-house prototyping and testing of new device designs and 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 specifications, hardware design description, electrical schematics, risk analyses, engineering drawings, specification control drawings, block diagrams, electrical design documents, etc.
• Establish and manage device design history file (DHF) and technical file
• Interact with suppliers/vendors to help design/select components for product devices
• Contribute to intellectual property evaluations
• Participate in multiple project teams
Requirements Skills required:
• Experience with hands-on electronics in the medical device or other regulated industry
• Analog and digital circuit design and analysis, microcontroller-based design and
embedded software development
• Experience with test fixture design using Lab View and other tools
• 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
• 8-12 years of experience in hardware, design, electrical, or electronics engineering related to the development of medical devices; aerosol drug delivery device experience is a plus
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