Responsibilities:

Develop, maintain, and manage system-level and subsystem requirements, system architectures, and integration strategies while ensuring requirements are complete, traceable, and verifiable. Lead verification and validation activities by developing test plans, protocols, reports, statistical analyses, and data-driven conclusions to confirm product performance, safety, and compliance. Design, qualify, and validate custom and commercial test equipment, incorporating applicable industry standards into testing methodologies and product evaluations. Own product risk management activities, including hazard analyses, FMEA development, risk documentation, and maintenance of risk management processes in accordance with medical device standards. Create and maintain technical documentation, including requirements specifications, traceability matrices, validation documentation, and engineering reports supporting design controls and regulatory compliance. Collaborate with cross-functional engineering, quality, regulatory, and project management teams to resolve technical challenges, support product development, and ensure successful project execution.

Qualifications:

Bachelor's degree in Engineering required; advanced degree or specialized medical device training is preferred. 5+ years of experience in medical device product development with strong expertise in systems engineering, requirements management, and verification and validation activities. Experience developing risk management documentation, FMEAs, hazard analyses, custom test equipment, and supporting medical device design controls and regulatory requirements. Strong understanding of medical device quality systems, engineering documentation, statistical data analysis, and product lifecycle development within regulated environments. Excellent communication and technical presentation skills with the ability to simplify complex engineering concepts and collaborate effectively across multidisciplinary teams. Ability to work full-time on-site in the Raleigh, North Carolina area. #accentuate2

Job Type:

Full-time Pay:

$110,000.00 - $150,000.00 per year

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Medical Device Systems Test Engineer