Demo

Medical Device System Test Engineer

Katalyst Healthcares and Life Sciences
Raleigh, NC Full Time
POSTED ON 3/1/2025
AVAILABLE BEFORE 5/25/2025

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 Manufacturing, 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.
  • 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.

Requirements :

  • Medical Device Test.
  • User Requirements Defining and Managing.
  • Verification and Validation and Testing.
  • Documentation Technical Writing.
  • Experience with standards compliance such as IEC 60601, ISO 13485, and / or ISO 14971.
  • FDA regulated industry or willing to learn.
  • Bachelor's degree.
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