Laza Medical · 2 days ago
Staff/Principal Software Quality Engineer
Laza Medical, a Shifamed Portfolio Company, is dedicated to advancing cardiovascular imaging solutions through robotics and AI. The Staff/Principal Software Quality Engineer will lead quality initiatives in software product development, collaborating with cross-functional teams to ensure compliance with regulatory standards in the medical device industry.
Responsibilities
Lead as a quality core team member responsible for driving quality into the design and development of software solutions
Lead quality focused design and development of software within the software development lifecycle (Agile/Waterfall/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability
Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review, test results, verification and validation reports and defects
Lead and conduct risk management activities including system risk analysis and software FMEA’s
Participate in both internal and external regulatory audits and inspections
Manage compliance to standards for software quality operating methods, processes, and procedures (such as ISO 13485, IEC 62304, AAMI TIR 45, Security Standards, and Data Privacy)
Qualification
Required
Bachelor's degree in Engineering, Science or Technical Field with a minimum of 8+ years of experience in Engineering and/or Quality
Experience with software quality engineering activities for new product development
Ability to author technical reports, and standard operating procedures
Exposure to medical imaging solutions leveraging machine learning/ artificial intelligence (AI)
Demonstrated ability to support multiple projects
Benefits
Equity
Benefits
Company
Laza Medical
Laza Medical is a startup focused on producing a high-quality AI-powered robotic imaging solution for cardiovascular treatments.
Funding
Current Stage
Early StageTotal Funding
$36MKey Investors
The Capital Partnership
2023-12-12Series A· $36M
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