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Engineer Electrical

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Location
Any US City
Job Type
Direct Hire
Date
Dec 26, 2016
Job ID
2434966

Engineer Electrical 
Main Objective:
Responsible for support and development of Class I and II medical devices, which includes, production support, service support, troubleshooting, design transfer support, training, prototyping, design assurance testing, development support from prototype through production release.
Essential Duties and Responsibilities:
  • Design of electronics/firmware using modeling, simulation, and analysis
  • Electronic/Firmware/Software design in support of senior design engineering staff including test and test automation.
  • Image and signal processing
  • Electronics test and troubleshooting in support of production line and service department.
  • Proof of concept work including feasibility analysis, product/component research, design for test.
  • Production and Service Operator training as required.
  • Continuous improvement and optimization of production and service procedures in support of operations goals and objectives.
  • Support of Quality System deliverables (e.g. CAPA, investigations, DHR).
  • Create and optimize test plans including Design V&V protocols.
  • Perform and/or manage design V&V tests including results and conclusions.
  • Coordinate work with electrical and software engineering, and with contract engineering resources as required. 
  • Support development of budgets and timelines for projects.
  • Support design history file deliverables for assigned projects, adhering to design control procedures.
  • Provide Regulatory department technical support for assigned projects as needed.
  • Support Marketing and Product Management with technical information to be used for training and marketing of assigned products.
  • Report progress and status of assigned projects on a timely basis with emphasis on reporting results to Director of Engineering.
  • Some required domestic travel to support vendors and/or customers may be required.
 
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
 
Education and Experience:
Minimum of a Bachelor of Science Degree in Electrical Engineering required; MS preferred.
At least 3 years relevant engineering experiences required. 
Medical device company experience preferred.
 
Knowledge and Skill Requirements/Specialized Courses and/or Training:
  • Expert understanding of electronic design (analog and digital), manufacturing and assembly.
  • Strong experience in signal processing, image processing – Matlab experience a plus.
  • Proficient in electronics/firmware troubleshooting from component level through system level.
  • Strong and demos ratable knowledge of electronic test equipment (oscilloscopes, waveform analyzers, and typical lab equipment.
  • Knowledge of electronic design tools (schematic capture, pcb layout, simulation tools), preferably Altium.
  • Understanding of digital circuits and implementation including programmable components (e.g. FPGAs).
  • Demonstrable knowledge of full life medical product development
  • Demonstrable knowledge of Design for Test, and Test Automation.
  • Working knowledge of medical device electrical safety standards.
  • Knowledge of endoscopic surgery preferred
  • Knowledgeable of FDA and ISO guidelines for the development of medical devices
  • Strong communication skills and accountability to project deliverable timing
 
Machine, Tools, and/or Equipment Skills:
Knowledge of surgical equipment and instrumentation, electrical testing equipment, PC, Logic Analyzers, Oscilloscopes, Video waveform analyzer.
Bench top testing and troubleshooting with typical lab equipment.