Electrical safety engineer

Location: Lake Forest, CA
Salary: $65.00 USD Hourly - $80.00 USD Hourly
Description: Our client is currently seeking an Electrical Safety Engineer for a 12 month + contract.

Role Requirements:

1. Minimum Education and Experience:
BS + 2 years in medical device products safety/EMC compliance, and/or fully-accredited test labs
2. Proven experience in successfully being able to work cross functional teams

Core responsibilities:
Perform Safety, EMC and Wireless test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
Research and develop product EMC & Wireless requirements including selection of applicable standards & tests, with analyses to support global market access strategies for all electromechanical surgical instruments.
Support product development utilizing specialized EMI/EMC hardware and software within all stages of product development at the circuitry level (PCB level) as well as at the system level
Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams
Capable of performing EMI/EMC testing and troubleshooting of Alcon products in the EMC Lab and external labs.
Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost.
Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals.
Strong familiarity with the content of the 3rd edition of IEC 60601-1, at least the first amendment, preferably both amendments; and content of fourth edition of IEC 60601-1-2, including the first amendment. This familiarity should also include working knowledge of the test equipment used to assess products under these standards.
Requires having experience working with NRTL's for certifying products to these two standards.
Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety, EMC and Wireless verification test plans and test reports.
Effectively communicate complex concepts in formal/informal presentations and in technical reports; proven technical writing skills is required (assessed during interview).
Experience with Safety and EMC testing of electrical equipment and certification of wireless devices for global market access.
Experience with Product Safety testing requirements and procedures.
Experience with use and maintenance of commonly used safety and EMC test equipment, and calibration procedures. Experience on the following test equipment required - Chamber, spectrum analyzer, immunity test equipment, EFT surge test equipment, leakage measurements, dielectric test, ground continuity.
Working knowledge of IEC 60601-1 and IEC 60601-1-2 medical standards, and all applicable collateral and particular standards. Proven experience in applying state of the art EMC and RF design principles.

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