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Sr. Engineer - Electrical
Ref No.: 18-14429
Location: Thousand Oaks, California
Position Type:Prof (T)
Start Date / End Date: 10/29/2018 to 10/28/2019
Our client, a leading biopharmaceutical company is looking for a Sr. Engineer - Software. This is for an initial duration of 12 months and is located in Thousand Oaks, CA
 
Top Skill Sets:
  • Microcontroller experience, Need low voltage experience.
  • Medical device development process
  • Firmware/hardware integration
 
Description:
  • The Electrical Engineer will be based in Thousand Oaks, CA and will report to the Director of Device Engineering, Electrical and Software Development.
  • The Device Engineering, Electrical and Software Development department leads the development of the electrical, software, and firmware subsystems of electromechanical drug delivery devices.
  • The contract Electrical Engineer will be primarily responsible for design and analysis of low power electrical hardware, integration and testing of electrical and firmware subsystems for complex electromechanical drug delivery devices.
  • The Engineer will be a member of a technical cross –functional team and will interface with key partners and external vendors to develop new drug delivery devices.
  • As needed the Engineer will also be helping with developing detailed requirements, engineering specifications, verification & validation, and supporting regulatory submissions of these devices.
 
Travel: International and domestic travel of up to 25% might be essential.
 
Key responsibilities include:
  • Integrate firmware and electronics subsystems and manage interfaces and dependencies across the system.
  • Perform circuit design, simulation, analysis and PCB layout. Must have 3+ years of experience using Altium for PCB design.
  • Perform battery testing and power budgeting.
  • Perform in characterization tests and generate reports.
  • Participate in identifying test strategy and generating detailed test protocols. Perform formal verification and generate reports.
  • Participate in requirements, risks and mitigations reviews, and ensure subsystem requirements meet system requirements and applicable quality and regulatory standards.
  • Follow a disciplined product development process and participate in technical reviews and ensure robust deliverables and documentation traceability.
 
Basic Qualifications:
  • Doctorate Degree OR
  • Master's Degree and 3 years of Electrical or Computer Engineering experience OR
  • Bachelor's Degree and 5 years of Electrical or Computer Engineering experience OR
  • Associate's degree and 10 years of Electrical or Computer Engineering experience OR
  • High school diploma/GED and 12 years of Electrical or Computer Engineering experience
 
Preferred Qualifications:
  • 5+ years of experience in Medical Device/Combination Product development life cycle and knowledge of design control
  • Experience in multilayers mixed signal PCB designs and EMI mitigation
  • Experience in PCBA automated testing
  • Strong hands-on skill on prototyping, board bring-up and troubleshooting down to component level
  • Experience in low power microcontroller-based hardware and software designs
  • Familiarity with lab instruments such as oscilloscope, logic analyzer, and battery testing equipment
  • Familiar with the following standards: Quality System Regulation – 21CFR820, Quality Management – ISO 13485, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive, 93/42/EEC, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.