Impactful Medical Device System Test Engineer (Hybrid)

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

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.