Staff Quality Engineer (Design Assurance)

Cytovale • South San Francisco, CA

2d • Hybrid

About The Position

Cytovale is a leading innovator in early sepsis detection, revolutionizing emergency care with its advanced IntelliSep technology. This system provides rapid, actionable insights into a patient's likelihood of having or developing sepsis through a quick 8-minute blood test. IntelliSep's unique capability to assess immune dysregulation enhances the triage and treatment of sepsis, promoting patient-centered care, operational efficiencies, and provider satisfaction. Cytovale is committed to the successful implementation, clinical adoption, and continual improvement of healthcare outcomes. For more information, please visit www.cytovale.com.

As a Staff Quality Engineer, you will be a key member of the Quality Assurance team and responsible for supporting the product development lifecycle within the Cytovale QMS, guiding and contributing to design verification and validation efforts, managing requirements traceability and risk, and maintaining quality management system effectiveness.

Successful candidates will work well in a fast-paced startup environment, can balance priorities, demonstrate the ability to think critically, have a “can-do” attitude, and value cross-functional collaboration and continuous improvement.

Requirements

• Bachelor's Degree, applicable certification or equivalent experience required
• 7-10 years related experience in the medical device industry; IVD experience with systems and system integration (instrument, software, disposable, reagents, and controls) preferred.
• Knowledge of regulations and standards such as 21 CFR 820, ISO 13485, ISO 14971, IEC 61010, IEC 60601-1, etc.
• Prior experience in application of sampling plans and other statistical techniques desirable.
• This is a hybrid position, based in the San Francisco Bay Area.
• Role is 1-3 days / week onsite to support development and testing activities
• Ability to work in the United States
• Up to 10% domestic travel

Responsibilities

• Act as the Quality reviewer on hardware and software verification and validation documents to ensure accuracy, completeness and compliance to applicable regulations and standards.
• Support development and review of V&V protocols and reports, including test methods, sampling plans, equipment and tool qualifications, and testing to requirements.
• Review traceability of requirements, risk mitigations and V&V outputs. Lead and participate in Risk Management activities, including but not limited to risk assessment, DFMEA, PFMEA, etc.
• Collaborate with Engineering to develop and refine product and material specifications, including in-process testing, release testing, and acceptance criteria.
• Support design transfer activities to ensure design outputs are effectively translated into manufacturing specifications and processes
• Identify opportunities to improve test methods, documentation, and quality processes.
• Investigate nonconformances and deviations, and implement corrective and preventive actions in coordination with relevant cross-functional teams
• Monitor product field performance quality indicators, carry out supporting analysis, and drive improvements as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees