Senior Systems Engineer

FUJIFILM Corporation

. Lead cross-functional project teams in designing and developing medical imaging systems through the phase-gate product development process from concept to launch .

Posted 9/17/2026full-timeBothell • Washington • United StatesSenior💰 $110,000 - $160,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading cross-functional teams in the development of medical imaging systems, ensuring compliance with industry standards and regulations while effectively managing project deliverables and timelines.

Highest-signal resume keywords

Medical Imaging Product DevelopmentRegulatory ComplianceCross-Functional Team LeadershipRisk Management (ISO 14971)Project Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Systems Architecture DesignProduct DevelopmentClinical Scenario AnalysisDesign Testing and EvaluationMedical Device Safety Standards (IEC 60601-1)

Soft Skills

Excellent Communication SkillsStrong Interpersonal SkillsAnalytical SkillsOrganizational SkillsProblem-Solving Skills

Industry Keywords

Phase-Gate Product DevelopmentDHF ManagementFDA AuditsISO Audits510(k) Submissions

About the role

Key responsibilities & impact

Lead cross-functional project teams in designing and developing medical imaging systems through the phase-gate product development process from concept to launch
Ensure products and processes comply with applicable industry guidance, standards, and regulations
Work with clinicians, end users, and marketing to define and evaluate innovative product concepts addressing customer and business needs
Support sustaining engineering initiatives for strategic products manufactured in-house or at contract manufacturing sites
Support program management by managing technical product deliverables, including DHF
Monitor project progress, manage critical-path activities, and ensure adherence to milestones and timelines
Communicate project status through verbal and written reports to Senior Management
Facilitate engineering change request quorum to manage project scope and defects
Work with Quality and Regulatory Affairs on new-product regulatory activities, including country registrations and 510(k) submissions and follow-up
Respond to internal and external audits, including FDA and ISO audits
Participate in post-market investigations as needed

Requirements

What you’ll need

Undergraduate degree in an engineering or science discipline, including Biology, Biomedical Engineering, Chemistry, Chemical Engineering, Material Science, Mechanical Engineering, or another related discipline
Minimum of 7–9 years of R&D experience
Proven track record leading a team of Systems, BME, SW-E, ME, and/or EE engineers in product development and commercialization within a regulated industry, preferably medical imaging
Experience designing and developing system architectures is a plus
Ability to understand clinical scenarios and conceptualize technical solutions
Ability to explain concepts to implementation engineers
Ability to test and evaluate designs and prototypes
Knowledge of medical device risk management per ISO 14971 is preferred
Experience designing products and processes per industry standards
Exposure to medical device safety standards, including IEC 60601-1, is highly desired
Ability to lift 25 lbs with or without accommodations
Excellent written and verbal communication skills
Strong interpersonal, analytical, and organizational skills
Ability to work in a fast-paced, small-team environment with minimal direction
Ability to handle open-ended problems and ambiguity

Benefits

Comp & perks

Medical, Dental & Vision insurance
Life and company-paid disability insurance
Retirement plan (401k) with 4% automatic company contribution
Fujifilm matches 50 cents for every dollar contributed, up to 6% of salary
Up to 120 hours of accrued PTO in the first year
PTO increases based on years of service
32 hours of additional paid Employee Choice Holidays, based on date of hire
Eight paid holidays per year
Variable target bonus