Staff/Principal Software Quality Engineer

Shifamed•Campbell, CA

5h•$150,000 - $200,000

About The Position

Laza Medical, a Shifamed Portfolio Company, is at the forefront of developing state-of-the-art imaging solutions for cardiovascular applications. Our mission is to democratize top-quality cardiovascular imaging using robotics and AI. To learn more about Laza Medical, please visit https://lazamedical.com/. ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. Description: The Staff/Principal Quality Engineer will be responsible for driving quality into software product development at Laza Medical. This individual will work proactively with cross functional team members on software development lifecycle processes as applied within the regulated medical device industry.

Requirements

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.

Nice To Haves

Exposure to medical imaging solutions leveraging machine learning/ artificial intelligence (AI).
Demonstrated ability to support multiple projects.

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).