Ceribell │ AI-Powered Point-of-Care EEG
Senior Quality Engineer - Hardware
Ceribell │ AI-Powered Point-of-Care EEG, Sunnyvale, California, United States, 94087
Overview
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Senior QA Engineer
role at
Ceribell │ AI-Powered Point-of-Care EEG
Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform designed to address unmet needs in the acute care setting and is used in hundreds of community hospitals, large academic facilities and major IDNs across the country. Our team is committed to transforming the landscape of critical care through rapid seizure detection technology.
Position Overview The Senior Quality Engineer ensures product quality and compliance with regulations throughout the product lifecycle. Support design control activities, risk management activities, and verification/validation activities, ensuring products meet quality standards and regulatory requirements. Work closely with Operations, R&D, and Suppliers (as applicable) on new product activities and support production and continuous quality improvement, conduct audits, and support investigations related to quality issues. Applies Quality Engineering tools, techniques, and methodologies to product development according to the company’s needs and applicable regulations.
What you'll do
Design Controls & Product Development: Represent Quality Engineering in all Design Controls and Product Development related aspects; lead and support design control activities, ensuring compliance with ISO 13485 and 21 CFR 820, and implementing 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 including design inputs/outputs, verification/validation protocols and reports, risk management files, and design transfer records for completeness; ensure traceability between user needs, design inputs, design outputs, and verification/validation activities.
Apply Quality Engineering principles to development projects and drive the definition of design verification and validation test requirements with objective evidence to support acceptance criteria.
Support New Product Introduction (NPI) and change management processes with quality oversight.
Risk Management: Develop, maintain, and contribute to risk management documentation and processes throughout the product life cycle.
Manufacturing & Operational Quality: Lead materials review, review/approve nonconforming material, resolve quality problems with Operations and suppliers, establish process control and manufacturing metrics, and support failure investigations.
Supplier Quality: Interface with suppliers for new processes, quality issues and improvements; manage supplier quality performance, audits, ASL, and cross-functional integration with R&D, manufacturing and procurement.
Quality Systems & Compliance: Conduct audits, maintain quality systems per ISO 13485 and regulatory requirements, and perform gap assessments as assigned.
CAPA & Continuous Improvement: Investigate issues, implement corrective/preventive actions, lead CAPA investigations related to design issues, and drive Lean/Six Sigma or other quality improvements.
Data & Performance Analysis: Analyze quality data, generate reports on trends, and monitor KPIs through audits and inspections.
Cross-Functional Collaboration: Partner with R&D, Regulatory Affairs, and Manufacturing to support product launches, design transfers, and change control.
What We're Looking For
Bachelor's Degree in the engineering discipline, or equivalent
CQE, RAC, RAB, ASQ or other quality/regulatory certificates 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, IEC62366, IEC62304, 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 Jira, Minitab, DOORS, or equivalent platforms used for traceability and risk analysis
Ability to lead quality initiatives and drive continuous improvement with a proactive, solutions-oriented mindset
Effective communicator with strong interpersonal skills, able to collaborate across levels of the organization, suppliers, and customers
Strong team player with a commitment to product excellence and quality
Ability to maintain accurate, compliant documentation within a regulated environment
Willingness to travel internationally (up to 20%)
Compensation & Benefits
Compensation Range: $101,000—$140,000 USD
Annual Bonus + Equity Opportunity
100% Employer paid Health Benefits for Employees
50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection)
100% paid Life and Long-Term Disability Insurance
401(k) with a 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
Excellent parental leave policy
Fantastic culture with tremendous career advancement opportunities
Joining a mission-minded organization
Employment Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
Industry: Medical Equipment Manufacturing
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Senior QA Engineer
role at
Ceribell │ AI-Powered Point-of-Care EEG
Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform designed to address unmet needs in the acute care setting and is used in hundreds of community hospitals, large academic facilities and major IDNs across the country. Our team is committed to transforming the landscape of critical care through rapid seizure detection technology.
Position Overview The Senior Quality Engineer ensures product quality and compliance with regulations throughout the product lifecycle. Support design control activities, risk management activities, and verification/validation activities, ensuring products meet quality standards and regulatory requirements. Work closely with Operations, R&D, and Suppliers (as applicable) on new product activities and support production and continuous quality improvement, conduct audits, and support investigations related to quality issues. Applies Quality Engineering tools, techniques, and methodologies to product development according to the company’s needs and applicable regulations.
What you'll do
Design Controls & Product Development: Represent Quality Engineering in all Design Controls and Product Development related aspects; lead and support design control activities, ensuring compliance with ISO 13485 and 21 CFR 820, and implementing 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 including design inputs/outputs, verification/validation protocols and reports, risk management files, and design transfer records for completeness; ensure traceability between user needs, design inputs, design outputs, and verification/validation activities.
Apply Quality Engineering principles to development projects and drive the definition of design verification and validation test requirements with objective evidence to support acceptance criteria.
Support New Product Introduction (NPI) and change management processes with quality oversight.
Risk Management: Develop, maintain, and contribute to risk management documentation and processes throughout the product life cycle.
Manufacturing & Operational Quality: Lead materials review, review/approve nonconforming material, resolve quality problems with Operations and suppliers, establish process control and manufacturing metrics, and support failure investigations.
Supplier Quality: Interface with suppliers for new processes, quality issues and improvements; manage supplier quality performance, audits, ASL, and cross-functional integration with R&D, manufacturing and procurement.
Quality Systems & Compliance: Conduct audits, maintain quality systems per ISO 13485 and regulatory requirements, and perform gap assessments as assigned.
CAPA & Continuous Improvement: Investigate issues, implement corrective/preventive actions, lead CAPA investigations related to design issues, and drive Lean/Six Sigma or other quality improvements.
Data & Performance Analysis: Analyze quality data, generate reports on trends, and monitor KPIs through audits and inspections.
Cross-Functional Collaboration: Partner with R&D, Regulatory Affairs, and Manufacturing to support product launches, design transfers, and change control.
What We're Looking For
Bachelor's Degree in the engineering discipline, or equivalent
CQE, RAC, RAB, ASQ or other quality/regulatory certificates 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, IEC62366, IEC62304, 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 Jira, Minitab, DOORS, or equivalent platforms used for traceability and risk analysis
Ability to lead quality initiatives and drive continuous improvement with a proactive, solutions-oriented mindset
Effective communicator with strong interpersonal skills, able to collaborate across levels of the organization, suppliers, and customers
Strong team player with a commitment to product excellence and quality
Ability to maintain accurate, compliant documentation within a regulated environment
Willingness to travel internationally (up to 20%)
Compensation & Benefits
Compensation Range: $101,000—$140,000 USD
Annual Bonus + Equity Opportunity
100% Employer paid Health Benefits for Employees
50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection)
100% paid Life and Long-Term Disability Insurance
401(k) with a 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
Excellent parental leave policy
Fantastic culture with tremendous career advancement opportunities
Joining a mission-minded organization
Employment Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
Industry: Medical Equipment Manufacturing
#J-18808-Ljbffr