Built by clinicians, biomed engineers, and regulatory professionals.

Mission

Make critical-care monitoring programs easier to trust at the bedside and easier to defend under FDA, CE MDR, and hospital value analysis review. Our teams focus on measurement consistency, service readiness, documentation discipline, and user training that holds up during a 3 a.m. escalation.

Vision

By 2030, every Edwards Lifesciences monitoring deployment should be supported by clear SBOM disclosure, practical HL7 FHIR integration guidance, and a lifecycle service record that follows the device from installation through replacement planning.

Patient-First Engineering

Risk management is not a late-stage document. ISO 14971 thinking guides usability, alarm behavior, training content, and post-market monitoring from the first design conversation.

QMS Discipline

ISO 13485 practices are treated as daily operating habits, with DHF, DMR, DHR, CAPA, supplier controls, and change review kept understandable for cross-functional teams.

Clinician Co-design

Critical care nurses, intensivists, anesthesiology teams, and biomedical engineers inform workflow decisions so monitoring data can be acted on quickly and consistently.

Regulatory as a Skill

Regulatory affairs partners with engineering and service teams early, translating clearance pathways, PMS obligations, UDI traceability, and complaint handling into practical work.

Service Culture

Engineers spend time with field service and application specialists so design choices reflect installation complexity, parts access, and training realities across hospital networks.

Inclusive Hiring

Talent pipelines include biomedical technician programs, clinical application specialists, RA apprenticeships, and community college partnerships that strengthen service coverage.

Open roles across clinical application, RA, service, and connected monitoring.

We look for people who can move between hospital reality and documentation discipline: RA Specialist, Biomed FSE, Clinical Application Specialist, SaMD Engineer, and Service Operations Lead.

Contact Talent Team