Back to jobs

Staff Software Quality Engineer

Sunnyvale

About Ceribell

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 specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN’s across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!

Position Overview:

We are seeking a detail-oriented and highly skilled Medical Device Software Quality Engineer to join our Quality Assurance team. The engineer will be responsible for championing quality assurance throughout the software development lifecycle, ensuring that all processes adhere to high standards and corporate requirements. The successful candidate will play a key role in ensuring the quality, safety, and compliance of software used in medical devices. You will work closely with software engineers, product managers, and regulatory teams to define and execute quality processes and activities that meet industry standards and regulatory requirements, including FDA Design Controls CFR 820.30, IEC 62304 – Software in a Medical Device, IEC 82304 – Software as a Medical Device, IEC 14971 – Risk Management, ISO 13485 – Quality Management Systems, 2017/745 – European Union Medical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, and General Principles of Software Validation. This role will also assist on maintaining quality systems, supporting Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCR), complaints, audits, and overall Quality Management System (QMS) functions.

What you'll do:

  • Act as a champion of Quality Assurance throughout the software development lifecycle, ensuring adherence to high standards and corporate requirements.
  • Develop and implement quality assurance processes for medical device software development, ensuring compliance with FDA, ISO 13485, IEC 62304, and other relevant standards.
  • Collaborate with software engineers, hardware engineers, and cross-functional teams to review design specifications, requirements, and software documentation for compliance with quality standards.
  • Conduct software risk assessments and contribute to risk management activities, including hazard analysis, FMEA (Failure Modes and Effects Analysis), and software safety analysis.
  • Develop and execute software verification and validation (V&V) plans to ensure software functionality, performance, and safety meet required standards.
  • Lead software quality audits and reviews, ensuring adherence to quality systems, processes, and regulatory requirements.
  • Ensure proper documentation and traceability of quality activities, including test plans, test cases, defect reports, and validation protocols.
  • Support the preparation and review of regulatory submissions, such as 510(k) filings or CE marking applications, ensuring the software quality processes are adequately documented.
  • Troubleshoot and manage software-related quality issues, working closely with development teams to resolve defects and improve software reliability.
  • Participate in design control activities to ensure software quality throughout the product lifecycle, including planning, development, testing, and post-market surveillance.
  • Assist in the training and development of team members on software quality standards, best practices, and regulatory requirements.
  • Stay up-to-date with industry standards, regulatory changes, and emerging trends in medical device software quality management.

What We're Looking For: 

  • Bachelor’s degree in Computer Science, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical field (Master’s preferred), or equivalent experience.
  • Minimum of 8 years of software quality engineering, experience in planning, creating and executing test cases particularly in medical device development with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience.
  • Strong knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971.
  • Experience in software verification and validation processes for embedded software and medical device software systems.
  • Strong understanding of software development life cycle (SDLC) and best practices for quality assurance and control.
  • Familiarity with programing language, software test tools, automated testing, and defect management systems.
  • Excellent problem-solving, analytical, and troubleshooting skills.
  • Strong attention to detail with a commitment to delivering high-quality, compliant products.
  • Excellent written and verbal communication skills, with the ability to work collaboratively in a cross-functional team environment.
  • Strong interpersonal skills including the ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team.
  • Experience with risk management practices, including risk analysis and mitigation strategies.
  • Must be able to handle multiple tasks/projects and manage priorities accordingly.

Preferred Skills and Experience:

  • Experience with software quality systems for Class II or III medical devices.
  • Familiarity with AI/ML based medical device software quality management.
  • Familiarity with FDA software validation, design controls, and regulatory submission requirements (510(k), PMA).
  • Experience with software tools such as JIRA, TestRail, or similar defect tracking and test management platforms.
  • Experience with agile development methodologies and software development tools.
  • Certification in quality management or software quality (e.g., ASQ, CMMI) is a plus.

In addition to your base compensation, Ceribell offers the following:

  • 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!

Compensation Range

$147,000 - $165,000 USD

Create a Job Alert

Interested in building your career at Ceribell, Inc? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...

By selecting this box and submitting this application, I confirm that I have reviewed the job description for this position. I acknowledge that I can perform the essential duties with or without reasonable accommodation.  

Select...
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Ceribell, Inc’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.