Senior Design Quality Engineer
Job Location:
El Segundo, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 40000 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.
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.
Education: Bachelors 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 FDAs 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.
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 employees 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 $120000 - $160000. 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 employees 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.
Required Experience:
Senior IC
About Company
Enabling early detection of respiratory failure powered by contactless sensing, clinic software, and artificial intelligence.
