Fujifilm medical device cleanroom assembly

People behind the process

Built by Clinicians, Biomed Engineers, and Regulatory Pros.

Mission

Make infection-control consumables that hold up under FDA inspection and in a 3 a.m. CSSD surge when case carts cannot wait.

Vision

By 2030, every Fujifilm healthcare consumable family we publish for evaluation will ship with SBOM-disclosed digital companions where networked, and UDI-native lot genealogy by default.

Culture

Six Values That Shape Design Reviews

Patient-First Engineering

ISO 14971 risk thinking is baked into design reviews, not appended after tooling.

QMS Discipline

ISO 13485 is lived in lot release and CAPA cadence, not framed on a wall.

Clinician Co-design

Infection preventionists and CSSD leads sit on advisory boards for high-volume SKUs.

Regulatory as a Skill

RA specialists are engineering peers who speak DHF, DMR, CER, and PMS fluently.

Service Culture

Every process engineer rotates through field complaint triage for sterile packaging.

Inclusive Hiring

HBCU and community-college biomed pipelines feed FSE and RA entry roles.

Teams at work

From Cleanroom Seals to Hospital Floors

Clinical engineer reviewing sterilization indicators — Clinical applications

Regulatory affairs team reviewing DHF binders — Regulatory affairs

Field service engineer at hospital receiving dock — Field support

Cleanroom pouch sealing station — Cleanroom assembly

Customer sterile processing training session — Customer training

R&D whiteboard infection-control session — R&D reviews

Open Roles

RA Specialist · Biomed FSE · Clinical Application Specialist · Sterile Packaging Engineer · PMS Analyst

Inquire about openings