Circadia Health

AI-powered contactless vital signs monitoring

Senior Design Quality Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeEl Segundo, CA, USA$120k - $160k /yr

About the Job

Requirements

Bachelor’s degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, or a related technical field.
At least 5 years of design quality engineering experience in the medical device or digital health industry.
Experience building processes from scratch in a fast-paced environment and taking ownership of ambiguous, evolving work.
Direct experience building and implementing an ISO 13485 Quality Management System.
Hands-on proficiency in Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, and Post-Market Surveillance.

Responsibilities

Lead the design, implementation, and rollout of an ISO 13485-compliant Quality Management System.
Establish and standardize quality procedures for document control, change management, CAPA, nonconformance, and audit readiness.
Ensure organizational alignment with ISO 13485 and prepare the company for FDA inspections and Notified Body audits.
Establish and execute end-to-end complaint handling processes, root-cause investigations, and medical device reporting evaluations.
Drive CAPA and nonconformance processes, perform root-cause analyses, and implement corrective and preventive actions.
Design and maintain the Post-Market Surveillance system, generating surveillance reports, clinical evaluation updates, and data-trending summaries.
Support execution and maintenance of design control activities across the product lifecycle.
Maintain Design History File documentation for company products.
Assist with preparation and review of design inputs and outputs, risk management documentation, verification and validation documentation, and design review records.
Track design control deliverables and coordinate documentation across teams.
Assist in preparing FDA submission documentation, including 510(k) documentation.
Support compilation and organization of testing documentation and reports.
Track regulatory submission deliverables and supporting evidence.
Coordinate with R&D, Engineering, Customer Success, Operations, and Clinical teams to collect documentation and evidence.
Support coordination of human factors validation and cybersecurity testing.
Assist with collection of third-party testing documentation.

Desired Qualifications

Direct experience or working knowledge of the FDA’s updated Quality Management System Regulation (QMSR).
Experience with Software as a Medical Device (SaMD) and/or software in a medical device (SiMD), firmware/hardware integration, human factors validation, and cybersecurity.
Direct involvement in successful FDA submissions or European CE mark technical files.
ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Green/Black Belt certification.

Salary Range: 120000 to 160000 (Currency: USD) (Pay period: per-year-salary)

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.

About the Role

Circadia Health is looking for a Senior Design Quality Engineer to establish and lead our quality engineering processes from the ground up. In this role, you will build, implement, and scale our Quality Management System (QMS) in alignment with ISO 13485 and FDA QMSR. You will take full ownership of design controls across the product lifecycle, establish robust complaint handling and CAPA workflows, and lead post-market surveillance activities. This role requires a hands-on, startup-savvy engineer who thrives in fast-paced environments.

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.

Circadia Health is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other status protected by law.

About the Company

Circadia Health

AI-powered contactless vital signs monitoring

Circadia Health offers AI-powered, contactless patient monitoring for senior care. A bedside radar device tracks respiratory rate, heart rate, motion, and bed exits from up to eight feet away, with its data analyzed by AI to predict health events hours or days in advance; virtual nurses review the signals and provide 24/7 predictive risk alerts, integrated into electronic health records. The system is FDA-cleared (C100 for respiratory rate in 2020 and C200 for heart rate, motion, and bed exit in 2024) and is offered on a subscription basis to skilled nursing facilities and other long-term care providers. Its goal is to move healthcare from reacting to problems toward predicting and preventing deterioration, reducing preventable hospitalizations and care costs while improving senior outcomes.

Company size: 51-200
Company stage: N/A
Total funding: $100.2M
Headquarters: London, United Kingdom
Founded: 2016

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