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Principal Electrical Design Engineer

Location: Mountain View, CA, United States
Job # 10341100
Date Posted: 01-19-2018
Principal Electrical Design Engineer
Mountain View, CA 94043
Salary Rate: Depends on Experience
Direct Hire Role
 
About Company and Opportunity:
Our client is a leading venture backed pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Their products are based on the Staccato system, a hand-held inhaler designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner. This is a permanent opportunity to grow with a fast paced pharma company including benefits, PTO, and retirement plans. You will be a major contributor to our organization and essential to the growing need in our Research and Development department.
 
Essential Job Duties:
  • 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 trade off 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
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:
  • BS in Electrical Engineering 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
If qualified, please apply with your resume in PDF or Word format. If you have any questions or would like to discuss further, please reach out to Tim Hendrickson, Director of Recruiting at TargetCW at Tim@TargetCW.com or (858)810-3050. Thanks! #DI
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