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.

Responsibilities

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.

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.