Job Description

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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