Medical device cleanroom assembly for monitoring sensors

Edwards Lifesciences — built by clinicians, biomed engineers, and regulatory pros

Mission

Make life-critical monitoring devices that hold up under FDA inspection and in a 3 a.m. ICU code—where SpO2 accuracy, alarm priority, and MTTR matter more than slogans.

Vision

By 2030, every Edwards Lifesciences connected monitor shipped for covered markets will be SBOM-disclosed and HL7 FHIR observation-ready for hospital IT review.

Culture values

How monitoring programs stay trustworthy

Patient-First Engineering

ISO 14971 risk thinking baked into design reviews for sensors, cables, and software alarms.

QMS Discipline

ISO 13485 lived daily through DHF, DMR, DHR, and CAPA routines—not framed on a wall.

Clinician Co-design

Every major monitoring family has a physician and nursing advisory board for workflow fit.

Regulatory as a Skill

RA teammates sit with engineers on 510(k), MDR technical files, and PMS evidence packs.

Service Culture

Every design engineer rotates through field service to feel bedside restore pressure.

Inclusive Hiring

HBCU and community-college biomed pipelines feed FSE and clinical application roles.

Teams behind the monitoring stack

Clinical engineer at monitoring console — Clinical engineering

Regulatory affairs team reviewing technical file — Regulatory affairs

Field service engineer servicing hospital monitor — Field service

Cleanroom sensor assembly station — Cleanroom assembly

Customer clinical training session — Clinical training

R and D whiteboard session for alarm design — R&D design reviews

Open roles

RA Specialist · Biomed FSE · Clinical Application Specialist · SaMD Engineer · Alarm Systems Lead

Talk with Talent Partners