About Circadia Health
Circadia Health is a growth-stage healthcare AI company on a mission to prevent avoidable hospitalizations and transform senior-care operations. Our Circadia Intelligence Platform combines:
Contactless sensing that monitors respiration and motion with medical-grade accuracy
Native predictive models that detect 85% of preventable adverse events several days in advance
Enterprise integrations that operationalize predictions directly inside EHR, care-coordination, billing, and compliance workflows
Today, our technology touches 40,000+ post-acute patients daily across skilled-nursing, home-health, and home-care networks. We are backed by leading healthcare and AI investors and headquartered in El Segundo, CA.
Responsibilities
- QMS Architecture: Lead the design, implementation, and roll-out of an ISO 13485-compliant Quality Management System.
- Process Creation: Establish and standardize core quality procedures, including document control, change management, CAPA, nonconformance, and audit readiness.
- Compliance Standards: Ensure organizational alignment with ISO 13485 and prepare the company for FDA Inspections/Notified Body audits.
- Complaint Handling: Establish and execute end-to-end complaint handling processes, root-cause investigations, and medical device reporting (MDR) evaluations.
- CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions.
- Post-Market Surveillance (PMS): Design and maintain the Post-Market Surveillance (PMS) system, generating PMS reports, clinical evaluation updates, and data trending summaries.
- Support execution and maintenance of design control activities across the product lifecycle.
- Maintain Design History File (DHF) documentation for Circadia products.
- Assist with preparation and review of:
- Design inputs and outputs
- Risk management documentation
- Verification and validation documentation
- Design review records
- Track design control deliverables and coordinate documentation across teams.
- Assist in preparation of FDA submission documentation (e.g., 510(k)).
- Support compilation and organization of testing documentation and reports.
- Track submission deliverables and supporting evidence.
- Coordinate with R&D, Engineering, Customer Success, Ops and Clinical teams to collect documentation and evidence.
- Support human factors validation and cybersecurity testing coordination.
- Assist with third-party testing documentation collection.
QMS Building & Implementation
Post-Market Surveillance, Complaints & CAPA
Design Controls & Product Development Support
Regulatory Submission Support
Cross-Functional Collaboration
Qualifications
Education: Bachelor’s degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, or a related technical field.
Senior-Level Expertise: 5+ years of design quality engineering experience within the medical device or digital health industry.
Startup Track Record: Proven experience in a fast-paced environment where you built processes from scratch rather than executing existing ones, and are comfortable owning ambiguous, evolving work.
QMS Implementation: Direct experience building and implementing an ISO 13485 QMS
Subject Matter Ownership: Deep, hands-on proficiency in Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, and Post-Market Surveillance (PMS).
Nice to Have
QMSR Familiarity: Direct experience or working knowledge of the FDA’s updated Quality Management System Regulation (QMSR).
Digital Health / Hardware + Software: Experience with Software as a Medical Device (SaMD) and/or software in a medical device (SiMD), firmware/hardware integration, human factors validation, and cybersecurity.
Regulatory Submissions: Direct involvement in successful FDA submissions or European CE mark technical files.
Certifications: ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Green/Black Belt.
Skills Required
- Bachelor's degree in Biomedical, Software, Mechanical Engineering or related technical field
- 5+ years design quality engineering experience in medical device or digital health
- Proven experience building processes from scratch in a fast-paced startup environment
- Direct experience building and implementing an ISO 13485 QMS
- Hands-on proficiency in Design Controls, Risk Management (ISO 14971), CAPA, Complaint Handling, and Post-Market Surveillance
- Experience supporting FDA submissions and compiling testing documentation (e.g., 510(k))
- Working knowledge of the FDA QMSR
- Experience with SaMD or software in medical devices, firmware/hardware integration, human factors, and cybersecurity testing
- Experience with CE technical files or successful regulatory submissions
- Certifications such as ASQ CQE, CSQE, or Six Sigma Green/Black Belt
What We Do
Circadia Health helps reduce preventable rehospitalizations and save lives across the post-acute care continuum. Our AI-powered early detection system combines proprietary sensor technology – the Circadia C200 System (FDA-cleared) for contactless respiratory, heart rate, and motion monitoring – with EHR data and care coordination. We are venture-backed and in a rapid growth stage. Our US headquarters is in Los Angeles, and we have just opened an office in NYC.
Why Work With Us
We fuse hardware, software, data science, and clinical services to provide a full-stack virtual care delivery model across SNFs and Home. We are a team of designers, engineers, clinicians, and scientists.
