Hardware Test Engineer

Fulfill Team Inc.; North Carolina; Hybrid; USD 90,000 - 120,000; Full time

Job summary

Fulfill Team Inc. is seeking a Medical Device System Test Engineer for a hybrid contract-to-permanent full-time role in Raleigh, NC.

The position focuses on verification and validation of medical device hardware, firmware, software, and integrated systems to ensure performance and compliance with medical device standards. Responsibilities include defining user requirements, developing test methods and protocols, and maintaining design control documentation.

Qualifications

• Experience with verification and validation of medical devices.
• Familiarity with IEC 62304, ISO 13485, and ISO 14971.
• Experience in FDA-regulated environments.
• Strong documentation and technical writing skills.

Responsibilities

• Define and manage user requirements.
• Perform verification, validation and testing of hardware, firmware, software and integrated systems.
• Develop test methods and protocols.
• Document design control activities and technical reports.
• Support Manufacturing, Service and Training as needed.
• Maintain compliance with applicable standards.

Skills

System Test

Requirements Management

Documentation Writing

Job description

Medical Device System Verification / Validation / Test Engineer needed for a hybrid Contract to Permanent Full-Time position in Raleigh, NC.

Required/Desired Skills/Experiences include:

• Medical Device Quality Test
• System Test – Hardware, Software, Firmware, Electronics
• 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

As a Medical Device System Test Engineer, your responsibilities include:

Helping to define and manage User Requirements. Performing verification and validation and testing of medical device hardware, firmware, software, and integrated systems to ensure performance metrics are achieved and in compliance with standards such as IEC 62304, ISO 13485, and/or ISO 14971. Documenting performance and compliance including Technical Writing documentation.

Essential Functions/Responsibilities Include Testing the following:

• 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.