Software Quality Engineer/Senior Software Quality Engineer- Medical Device
Apply NowCompany: Ceribell
Location: Sunnyvale, CA 94087
Description:
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!
Ceribell, Inc. is a pioneer in developing cutting-edge medical devices designed to enhance patient care and improve outcomes. We are driven by innovation, regulatory compliance, and the commitment to delivering safe and effective medical solutions. Join our talented team of engineers and quality professionals to contribute to advancing healthcare through technology. Our work environment is fast paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient's experience. We are looking for like-minded individuals to join our team today.
Position Description:
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.
Responsibilities:
Requirements/Qualifications
Preferred Skills and Experience:
In addition to your base compensation, Ceribell offers the following:
Compensation Range
$95,000-$130,000 USD
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!
Ceribell, Inc. is a pioneer in developing cutting-edge medical devices designed to enhance patient care and improve outcomes. We are driven by innovation, regulatory compliance, and the commitment to delivering safe and effective medical solutions. Join our talented team of engineers and quality professionals to contribute to advancing healthcare through technology. Our work environment is fast paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient's experience. We are looking for like-minded individuals to join our team today.
Position Description:
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.
Responsibilities:
- 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.
Requirements/Qualifications
- Bachelor's degree in Computer Science, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical field (Master's preferred), or equivalent experience.
- At least 3-5 years of experience in software quality engineering, experience in planning, creating and executing test cases particularly in medical device development.
- 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 Opportunity + Ceribell Equity
- 100% Employer paid Health Benefits for the Employee
- 50% - 70% Employer paid Health, Dental & Vision for dependents (according to plan selection)
- Life & Long-term disability insurance paid 100% by Ceribell
- Monthly cell phone stipend
- Flexible paid time off
- 11 Paid Holidays
- Excellent parental leave policy
- Fantastic culture with tremendous career advancement opportunities
- Joining a mission-minded organization!
Compensation Range
$95,000-$130,000 USD