Job Description

Medical Device Electronic Hardware Systems Integration Engineer needed for a Permanent Full-Time position or a contract to hire position in Raleigh, NC.

Required/Desired Skills/Experiences include:

• Medical Device Electronic Hardware Systems Integration Engineering
• ISO 13485, or ISO 14971, or IEC 62366
• Design control – hardware, firmware, software - compliance with regulations regarding specific product standards
• X-ray imaging technologies – preferred or willingness to learn
• Electrical engineering laboratory testing (oscilloscopes, function generators, spectrum and network analyzers etc).
• Medical devices design and commercialization under design control Project Management
• Bachelor’s degree

As a Medical Device Electronic Hardware Systems Integration Engineer , your responsibilities include:

Research, design and development of medical X-Ray equipment. This position is responsible for systems engineering requirements generation, design and testing, and for the design transfer to production, service, support and training. In addition technical support to customers, dealers, and field engineers.

• Systems engineering design, prototype development and testing based on requirements.
• Design transfer to production, service, support, training and supplier development and management.
• Carry out and lead technical investigations to ensure the highest level of customer satisfaction.
• Work closely with sales and customer service departments to ensure customer satisfaction.
• Work independently and also as part of the team.
• Ability to train other engineers.

ESSENTIAL FUNCTIONS/RESPONSIBILITIES

• Develop system and subsystem-level design specifications based on requirements
• Develop system and subsystem-level configurations
• Develop system and subsystem-level test methods and protocols
• Serve as design transfer liaison to Production, Service, Support, and Training
• Serve as technical support for key products to our customers, dealers and field engineers
• Prototype and test new circuit boards and improved revisions of existing circuit boards following medical devices design control methodology.
• Prototype and test new firmware and hardware-specific software for new and existing X-ray systems and subassemblies.
• Perform Windows imaging lifecycle processes.
• Manage the creation, maintenance, and deployment of Windows system images.
• Complete and submit all required design control documentation on time and accurately
• Completes assigned training and development courses assigned by management team
• Provide emergency on-call services as needed in partnership with Service and Support.
• Serves as a Representative for conventions and shows
• Understands and Complies with all FSE Guidelines as applicable to the role.
• Must comply with Radiation Safety Policy including the timely replacement of used badges
• Completes the Corrective Actions Policy as prescribed
• Displays highly developed organizational skills.
• Ability to prioritize, plan, and execute are key success factors in this position.
• Utilize exceptional interpersonal and communication skills for problem situations with customers and/or staff.
• Completion of additional projects and assignments as given by management.

If you can start a new career opportunity in Raleigh with 2 weeks’ notice, please rush your resume to be confidentially considered for this career opportunity!

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