Senior Quality Engineer - Hardware Job at Ceribell │ Point-of-Care EEG in Sunnyv

Overview

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a point-of-care EEG platform designed for acute care settings and is used in hundreds of hospitals nationwide. Our team is dedicated to transforming critical care through rapid seizure detection technology.

What You'll Do

Design Controls & Product Development

• Represent Quality Engineering in all Design Controls and Product Development aspects.
• Lead and support design control activities, including ISO 13485 and 21 CFR 820 compliance, and implement ISO 14971 risk management processes.
• Collaborate with cross-functional teams to manage design requirements, risk assessments, and design history file documentation.
• Review Design History File (DHF) documentation for completeness, including design inputs/outputs, verification/validation protocols and reports, risk management files, and design transfer records.
• Ensure traceability between user needs, design inputs, design outputs, and verification/validation activities.
• Apply Quality Engineering principles to development projects and drive design verification and validation planning with objective evidence and statistical support.
• Support New Product Introduction (NPI) and change management with quality oversight.

Risk Management

• Develop and maintain risk management documentation and processes across the product life cycle.

Manufacturing & Operational Quality

• Lead Manufacturing Quality activities, including Materials Review Board participation and nonconforming material review.
• Work with Operations to resolve in-house and supplier quality issues using established problem-solving methodologies.
• Establish process controls and manufacturing metrics with manufacturing and quality teams; report regularly.
• Support failure investigations and issue resolution for field failures in collaboration with Manufacturing, R&D, and Quality.
• Review engineering and manufacturing specifications for customer requirements and industry standards.
• Interface with Suppliers for new processes, quality issues, and process improvements; manage supplier quality and audits.
• Monitor supplier performance via KPIs and conduct supplier assessments and corrective actions (NCRs).
• Maintain Approved Supplier List and collaborate across R&D, manufacturing, and procurement to integrate supplier quality into development.
• Perform supplier facility audits (on-site and remote) to assess quality systems and compliance.

Quality Systems & Compliance

• Conduct internal and external audits for ISO 13485 and relevant standards; maintain QMS in compliance with regulatory requirements.
• Lead CAPA investigations for design issues and ensure timely closure; promote continuous improvement using Lean, Six Sigma, or similar methodologies.

Data & Performance Analysis

• Analyze quality data and generate trends to identify improvement opportunities; monitor quality performance via KPIs, audits, and inspections.

Cross-Functional Collaboration

• Collaborate with R&D, Regulatory Affairs, and Manufacturing to support product launches, design transfers, and overall product quality from design to delivery.
• Participate in Change Control processes for design and documentation updates.

What We're Looking For

• Bachelor's Degree in an engineering discipline or equivalent
• Quality/regulatory certifications (e.g., CQE, RAC, RAB, ASQ) are beneficial
• 3–5 years of quality experience in a medical device company, including design controls, product/process validation, and technical problem solving
• Strong knowledge of ISO 13485, ISO 14971, IEC 62366, IEC 62304, 21 CFR 820, and quality concepts (NC/CAPA)
• Proficiency in statistical analysis, trend analysis, and methodologies such as FMEA, root cause analysis, and risk assessment tools
• Experience with tools like Jira, Minitab, DOORS, or equivalent for traceability and risk analysis
• Ability to lead quality initiatives, troubleshoot complex issues, and drive continuous improvement with a proactive mindset
• Effective communicator with strong interpersonal skills and collaboration across all levels, including suppliers and customers
• Strong team player with a commitment to product excellence and quality
• Ability to maintain accurate, compliant documentation in a regulated environment
• Willingness to travel internationally (up to 20%)

In addition to base compensation

• Annual Bonus + Equity Opportunity
• 100% employer-paid health benefits for employees
• 100% paid life and long-term disability insurance
• 401(k) with generous company match
• Employee Stock Purchase Plan (ESPP) with a discount
• Monthly cell phone stipend
• Flexible paid time off
• 11 paid holidays + 5 company wellness days
• Parental leave policy; career advancement opportunities
• Culture and mission-driven environment

Compensation

$101,000 - $140,000 USD

Privacy & Compliance

For information on how Ceribell processes personal data of job applicants, please review our Privacy Policy.

Equal Opportunity

Ceribell is an equal opportunity employer. We do not discriminate on the basis of protected status. Voluntary self-identification of disability and other demographic information is requested in accordance with applicable laws and regulations. Providing this information is voluntary.