Senior Systems Engineer - Medical Devices & Requirements

INFOTRON; Palmer (AK); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

INFOTRON in Weston, FL is seeking an experienced Systems Engineer to support complex electro-mechanical products in a regulated environment with a strong emphasis on requirements engineering. The role requires a BS in Engineering and 10+ years of systems engineering experience, preferably in the medical field.

You will own platform and module requirements, drive DFMECA and ABD processes, and contribute to verification testing, tech reviews, and risk management. Medical device knowledge is a plus.

Formación

• BS in Engineering or related field.
• 10+ years of experience as a Systems Engineer in a regulated field (Medical preferred).
• Strong Systems Engineering experience focused on requirements.
• Experience working on complex electro-mechanical products.

Responsabilidades

• Platform requirements
• Module requirements
• Reliability
• DFMECA
• ABD
• Development/Integration testing (input to requirements and verification testing, including Engineering Studies)
• Labs (input to requirements)
• High-risk requirement test method development (technical or timeline risk, including Engineering Studies)
• Tech reviews
• Trade studies
• Functional Analysis (input to requirements)
• Technology knowledge ramp-up
• Print Reviews / DFM / SDD / SADD / SRA
• CQA

Conocimientos

Requirements engineering

Systems engineering

Regulated environment

Electro-mechanical systems

Technical reviews

Educación

Bachelor's degree in Engineering

Herramientas

DOORS

JAMA

IEC 60601

Descripción del empleo

INFOTRON in Weston, FL is seeking an experienced Systems Engineer to support complex electro-mechanical products in a regulated environment with a strong emphasis on requirements engineering. The role requires a BS in Engineering and 10+ years of systems engineering experience, preferably in the medical field.

You will own platform and module requirements, drive DFMECA and ABD processes, and contribute to verification testing, tech reviews, and risk management. Medical device knowledge is a plus.