ISO 13485 cleanroom dental implant assembly

Built by clinicians, biomed engineers, and regulatory pros.

Mission

Make life-critical dental devices that hold up under FDA inspection and in a Friday afternoon implant case when the schedule is already behind.

Vision

By 2030, every Zimmer Biomet networked dental device shipped will be SBOM-disclosed and HL7 FHIR-ready where the intended use includes connected exchange.

Culture

Six disciplines we hire and measure against

Patient-First Engineering

ISO 14971 risk thinking baked into design reviews before marketing copy is drafted.

QMS Discipline

ISO 13485 lived daily in DHF / DMR / DHR control — not framed on a lobby wall.

Clinician Co-design

Every major implant or digital platform has a physician advisory board for indication fit.

Regulatory as a Skill

RA specialists sit as engineering peers, not last-mile gatekeepers after tooling freezes.

Service Culture

Design engineers rotate through field service so IFU language matches chairside reality.

Inclusive Hiring

HBCU and community-college biomed pipelines for FSE and quality technician roles.

Teams

Where the work happens

Clinical engineer at imaging console
Clinical application engineering
Regulatory affairs team reviewing dossiers
Regulatory affairs
Field service engineer servicing dental mill
Field service
Cleanroom dental implant assembly
Cleanroom assembly
Customer clinical training session
Clinical training
R and D whiteboard session
R&D design reviews

Open roles

RA Specialist · Biomed FSE · Clinical Application Specialist · SaMD Engineer · Sterile Reprocessing Lead

Inquire about openings