🔥 20 hours ago
As a Developer Advocate, you will bridge engineering and developer relations by creating impactful content, engaging with the developer community, and driving adoption of Fireworks' AI platform.
Senior Design Quality Engineer
📅 Aug 7
ISO 13485FDA QMSRDesign ControlsISO 14971
📜 Description
- Build and implement an ISO 13485-compliant Quality Management System and prepare for FDA inspections and Notified Body audits.
- Create and standardize document control, change management, CAPA, nonconformance, and audit-readiness processes.
- Maintain design controls and Design History Files, coordinating design inputs and outputs, risk management, verification and validation, and design reviews.
- Support FDA submission documentation, including 510(k) materials, and organize testing reports and supporting evidence.
- Coordinate quality documentation and evidence with R&D, Engineering, Customer Success, Operations, and Clinical teams; support human factors and cybersecurity testing.
🛠️ Requirements
- 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.
✨ Benefits
- Establish complaint handling, root-cause investigations, medical device reporting evaluations, and post-market surveillance activities.
Full job description
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.
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.
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.
Responsibilities
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.
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