Lead Medical Imaging Systems Engineer

FUJIFILM Biotechnologies; Bothell (WA); Presencial; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental & Vision insurance

401(k) retirement plan with company 50

PTO 120 hours first year

Eight paid holidays

Descripción de la vacante

FUJIFILM Sonosite in Bothell, WA is seeking a Sr. Systems Engineer to lead R&D efforts for medical imaging systems. You will guide cross-functional teams through design, verification, and regulatory processes to ensure successful delivery.

The role emphasizes system architecture, risk management alignment, and collaboration with clinicians, engineering, and quality to meet FDA/ISO requirements while supporting post-market activities.

Formación

• Undergraduate degree in engineering or science; Graduate degree a plus.
• Minimum 7–9 years of R&D leadership experience in medical imaging or regulated industries.
• Experience in system architecture design is a plus.
• Knowledge of ISO 14971 risk management and IEC 60601-1 safety standards is preferred.

Responsabilidades

• Lead cross-functional teams to design and develop medical imaging systems per PDP from concept to launch.
• Ensure compliance with applicable industry guidance, standards, and regulations.
• Collaborate with clinicians, end users, and marketing to define new product concepts.
• Support sustaining engineering for in-house or contract-manufactured products.
• Assist program management with managing DHF deliverables and project milestones.
• Communicate project status to senior management and stakeholders.
• Facilitate engineering change processes and scope management.
• Support regulatory activities including 510(k) submissions and audits.
• Participate in post-market investigations as needed.

Conocimientos

English communication

Verbal communication

Interpersonal skills

Analytical skills

Organizational skills

Fast-paced work

Problem solving

Physical lifting

Educación

Undergraduate engineering or science degree

Graduate degree preferred

Descripción del empleo

FUJIFILM Sonosite in Bothell, WA is seeking a Sr. Systems Engineer to lead R&D efforts for medical imaging systems. You will guide cross-functional teams through design, verification, and regulatory processes to ensure successful delivery.

The role emphasizes system architecture, risk management alignment, and collaboration with clinicians, engineering, and quality to meet FDA/ISO requirements while supporting post-market activities.