Senior Design Quality Engineer – MedTech & SaMD

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

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