Senior Design Quality Engineer 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 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. ResponsibilitiesQMS Building & Implementation Post-Market Surveillance, Complaints & CAPADesign 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 QMSSubject Matter Ownership: Deep, hands-on proficiency in Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, and Post-Market Surveillance (PMS).$120,000 - $160,000 a year As a full-time Senior Design Quality Engineer, you will be employed by Circadia Health, Inc. The anticipated annual base salary range for this full-time position is $120,000 - $160,000. The base range is determined by role and level, and placement within the range will depend on a number of job-related factors, including but not limited to your skills, qualifications, experience, and location. Annual salary is only one part of an employee's total compensation package at Circadia Health. We also offer: Meaningful employee stock options 100% company-paid medical, dental, and vision coverage 401(k) Competitive time off with pay policies including vacation, sick days, and company holidays.
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.
