Lead Systems Engineer, Medical Imaging & Regulatory Deliverables

FUJIFILM; Bothell (WA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental & Vision

Life & Disability insurance

401k with company match

Paid Time Off and holidays

Job summary

FUJIFILM Sonosite is seeking a Sr. Systems Engineer to lead cross-functional teams in delivering medical imaging systems from concept through launch.

You will ensure compliance with FDA and ISO guidelines while collaborating with clinicians and marketing to shape innovative product concepts. The role demands 7–9 years of R&D leadership in regulated environments, strong system-architecture skills, and the ability to translate clinical needs into robust engineering solutions.

Qualifications

• Bachelor's degree in engineering or science; graduate degree preferred.
• 7–9 years R&D experience leading a team of engineers in medical imaging or regulated environments.
• Experience designing and developing system architectures is a plus.
• Ability to understand clinical scenarios and translate them into technical solutions.
• Knowledge of ISO 14971 risk management is preferred; IEC 60601-1 exposure is desired.

Responsibilities

• Lead cross-functional teams in developing medical imaging systems from concept to launch.
• Ensure compliance with industry guidance, standards, and regulations.
• Collaborate with clinicians, end users, and marketing to define and evaluate new concepts.
• Support sustaining engineering for strategic products manufactured in-house or at contract sites.
• Assist program management with strong project management for DHF activities.
• Communicate project status to senior management in verbal and written reports.
• Facilitate engineering change control to manage scope and defects.
• Support regulatory activities including 510(k) submissions and audits.
• Participate in post-market investigations as needed.

Skills

Communication

Interpersonal skills

Analytical skills

Organizational skills

Problem solving

Teamwork

Physical ability

Ambiguity tolerance

Education

Bachelor's degree in engineering or science

Graduate degree preferred

Job description

FUJIFILM Sonosite is seeking a Sr. Systems Engineer to lead cross-functional teams in delivering medical imaging systems from concept through launch.

You will ensure compliance with FDA and ISO guidelines while collaborating with clinicians and marketing to shape innovative product concepts. The role demands 7–9 years of R&D leadership in regulated environments, strong system-architecture skills, and the ability to translate clinical needs into robust engineering solutions.