Senior Design Quality Engineer

Circadia Health; El Segundo (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Stock options

100% company-paid medical, dental, and

401(k)

Paid time off

Team events

Job summary

Circadia Health is seeking a Senior Design Quality Engineer to establish and lead our quality engineering processes from the ground up. You will implement a QMS aligned with ISO 13485 and FDA QMSR, owning design controls, CAPA, complaint handling, and PMS across the product lifecycle.

We are looking for a hands-on, startup-savvy engineer with 5+ years of experience who can build processes from scratch and collaborate across R&D, engineering, and clinical teams to ensure regulatory readiness and

Qualifications

• Bachelor’s degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, or a related technical field.
• 5+ years of design quality engineering experience in medical device or digital health.
• Startup experience building processes from scratch in a fast-paced environment.
• Direct experience building and implementing an ISO 13485 QMS.
• Deep hands-on proficiency in Design Controls, ISO 14971 risk management, CAPA, complaint handling, and PMS.

Responsibilities

• Lead the architecture, implementation, and rollout of an ISO 13485‑compliant Quality Management System.
• Establish and standardize core quality procedures (document control, change management, CAPA, nonconformance, audit readiness).
• Align with ISO 13485 and prepare for FDA inspections/notified body audits.
• Own end-to-end complaint handling, root-cause analyses, and MDR evaluations; drive CAPA and NC processes; design PMS system and reports.
• Support design controls across the product lifecycle; maintain the Design History File (DHF); assist with design inputs/outputs, risk management, verification/validation, and design reviews.
• Assist in FDA submissions (e.g., 510(k)) and related testing documentation; track submission deliverables and supporting evidence.
• Coordinate with R&D, Engineering, Customer Success, Operations and Clinical teams; support human factors validation and cybersecurity testing coordination.

Skills

Design quality

ISO 13485

Startup environment

Risk management

CAPA management

Education

Biomedical Engineering

Software Engineering

Mechanical Engineering

Related technical field

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.

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.

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.

120000 - 160000 USD a year

As a full‑time [Title], you will be employed by Circadia Health, Inc. The anticipated annual base salary range for this full‑time position is $[range]. 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
• Impact: your work will influence care decisions for tens of thousands of seniors every day.
• Culture: hard‑working, mission‑driven, and collaborative — with weekly and monthly social events like yoga, beach bonfires, and Wednesday/Friday team lunches.

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
• Impact: your work will influence care decisions for tens of thousands of seniors every day.
• Culture: hard‑working, mission‑driven, and collaborative — with weekly and monthly social events like yoga, beach bonfires, and Wednesday/Friday team lunches.