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. The company is seeking a Medical Device Software Quality Engineer to ensure the quality, safety, and compliance of software used in medical devices.
Requirements
- 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.
- Experience with risk management practices, including risk analysis and mitigation strategies.
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.
Other
- 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.
- 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.
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
