Senior Design Quality Engineer

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.

QMS Building & Implementation

• 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.

Post-Market Surveillance, Complaints & CAPA

• 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.

Design Controls & Product Development Support

• 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.

Regulatory Submission Support

• 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.

Cross-Functional Collaboration

• 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.

• 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).

• 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.