Job Description

Perform EMC, electrical and mechanical product safety testing on new and existing medical devices to show compliance to global product safety standards. Strive to develop and expand Labs testing capabilities and oversee projects to support the growing lineup of the products and technologies.

* Perform EMC, RF and Safety Compliance testing on medical devices by reviewing and executing standard procedures and system test plans.
* Review product specifications, datasheets, test set-up instructions, test plans, and pre-evaluation documents to understand the objectives of assignments prior to starting testing.
* Understand requirements and testing methodologies to perform testing for compliance (e.g. IEC 60601-1-2, AIM 7351731, FCC part 15 & part 18, etc.).
* Setup test equipment and perform tests such as Radiated & Conducted Emissions, and Susceptibility (e.g. ESD, Burst, Surge, etc.).
* Set up and operate computer-controlled or manually-operated lab test equipment such as Antennas, Spectrum Analyzers, Signal Generators, RF Amplifiers and Oscilloscopes, etc.
* Perform sample handling and tracking for test purposes.
* Record test results, numerical and graphical data and document in compliance with quality system and operating procedures.
* Maintain EMC chamber and other Lab equipment load/availability schedule. Maintain all lab records.
* Work collaboratively with all Product Development teams. Coordinate with them and Product Safety engineers on sample receiving, logging, pre-conditioning, traceability, preparation, testing, etc.
* Communicate information with Product Safety staff and product teams (turn-around time, test progress, project status, etc.).
* Conduct routine operation, maintenance, calibration, qualification, and trouble-shooting of laboratory equipment and instruments.
* Assist in development, writing, review, and validation of test methods, laboratory SOPs, and other department-level operating and quality documents.
* Provide training, instructions, and oversight to other team members as required.
* Travel to external Test Labs to witness and support testing as necessary.
* May make recommendations regarding technical decisions relating to the interpretation and applicability of test standards.
* Build or modify test fixtures when appropriate.

* High school diploma or equivalent is required; Associates degree and/or vocation program in engineering or electronics technologies is preferred, equivalent experience and training will be considered.
* 2 or more years of hands-on experience with EMC and/or RF testing.
* Medical devices testing experience preferred, working knowledge of IEC 60601 family of standards is desired.
* Experience working in ISO 13485 Quality Management Systems.
* Must be PC literate including experience with Microsoft Office Products (Word, Excel, PowerPoint, etc.)
* Ability to read and utilize electronic schematics and wire diagrams.
* Working knowledge of basic electrical circuits and basic EMC testing concepts preferred.
* Working knowledge of typical EMC and electrical measurement equipment. (Oscilloscope, Function Generator, Spectrum Analyzer, Signal Amplifier,Multi-Meter, etc.).
* Being a resourceful, hands-on, problem solving individual with initiative and drive to get things done.
* Strong communication &organization skills with great work ethic.
* Currently active CSA, UL or ETL certification is a plus.
* Demonstrated mechanical/electrical problem solving skills.