Interoperability Engineer

We're hiring a Healthcare Interoperability Engineer (L3L4, Senior IC) to own the standards-compliance layer of our diagnostic and oncology SaMD platforms — from HL7/FHIR data transformation to regulatory documentation for CDSCO and ISO 13485/IEC 62304 compliance.

What you'll do:
Implement and profile FHIR R4 resources (Observation, Patient, Practitioner, Device, DiagnosticReport) across multiple enterprise/EHR integrations
Own HL7 v2.5 FHIR R4 transformation via Mirth Connect (channel design, error handling, DLQ management)
Manage and maintain LOINC code mappings across 35+ diagnostic tests
Implement SMART on FHIR (OAuth 2.0) authentication for EHR integrations
Produce regulatory documentation (SRS, SDP, risk files) per IEC 62304, ISO 13485, ISO 14971
Support CDSCO SaMD submissions (Class B IVD) for two product lines
Maintain SBOM & monitor CVEs (NVD) under IMDRF cybersecurity guidance

What we're looking for:
3+ years hands-on FHIR R4 implementation in production (not just spec knowledge)
Working knowledge of HL7 v2.x + hands-on Mirth Connect experience
Familiarity with LOINC code management
Experience with SMART on FHIR auth flows
Track record producing regulated software documentation (medical device/healthcare IT/pharma)
Strong technical writing — auditor-ready docs

Nice to have:
IEC 62304 / ISO 13485 QMS experience
CDSCO SaMD pathway knowledge (MD-14/MD-15)
FHIR validator / Touchstone conformance testing
Indian FHIR IG / NDHM ecosystem exposure
SBOM tools (CycloneDX, SPDX)
Clinical/health informatics or biomedical engineering background

Please share the resume to hrudayam@virgilhealthcare.com