Senior Systems Engineer, R&D — Lab Automation & Compliance

Ortho Clinical Diagnostics; City of Rochester (NY); Presencial; USD 100 000 - 130 000; Tempo integral

Resumo da oferta

QuidelOrtho is seeking a Staff Systems Engineer to lead system engineering activities in R&D, focusing on hardware/software integration and regulatory compliance. This onsite role in Rochester, NY requires strong problem-solving and the ability to mentor junior engineers while guiding large-scale projects.

Responsibilities include requirement management, risk analysis, design reviews, and collaboration with external partners to deliver automated lab solutions that meet customer and

Qualificações

• Bachelor’s degree in system engineering or related field; master’s preferred.
• Experience delivering products in regulated environments (medical, automotive, aerospace, defense).
• Experience with hardware/software development and lab/automation systems.

Responsabilidades

• Gather, analyze, and manage system requirements ensuring regulatory alignment.
• Lead design reviews and ensure compliance with design controls.
• Drive instrument and lab automation development with cost-effective solutions.
• Develop test plans to validate system performance, reliability, and safety.
• Collaborate with stakeholders and external partners to deliver product features.

Conhecimentos

Systems engineering

Hardware integration

Software integration

Regulated environment

Leadership

Formação académica

Bachelor’s degree in System Engineering

Master’s degree preferred

Ferramentas

Linux

Windows

System modelling tools

Descrição da oferta de emprego

QuidelOrtho is seeking a Staff Systems Engineer to lead system engineering activities in R&D, focusing on hardware/software integration and regulatory compliance. This onsite role in Rochester, NY requires strong problem-solving and the ability to mentor junior engineers while guiding large-scale projects.

Responsibilities include requirement management, risk analysis, design reviews, and collaboration with external partners to deliver automated lab solutions that meet customer and