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Software Quality Engineer/Senior Software Quality Engineer-Medical Device
| Company | Ceribell |
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| Location | Sunnyvale, CA, USA |
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| Salary | $95000 – $130000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Mid Level, Senior |
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Requirements
- 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.
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.
Preferred Qualifications
- 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.
