Sr. Software Quality Engineer

Location:

Northridge, CA, USA

Duration:

Full-Time

Shift Schedule:

Monday to Friday, 9:00 AM to 5:00 PM

Summary:

Join our team as a Sr. Software Quality Engineer in the vibrant community of Northridge, CA. This position offers the opportunity to drive quality into the design and development of cutting-edge digital health solutions. You will work collaboratively with cross-functional teams to ensure that our products meet the highest standards of quality and compliance.

Responsibilities:

• Engage as a quality core team member responsible for driving quality into the design and development of digital health solutions, including medical mobile device applications (iOS/Android), cloud technologies (AWS/IBM Watson), data reports, and AI/ML.
• Drive the collaborative quality strategy for projects in alignment with business goals for cross-functional teams, including R&D, Regulatory, Marketing, and Operations.
• Drive quality-focused design and development of software within the software development lifecycle (Agile, waterfall, SAFe, 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 FMEAs.
• Lead and drive CAPA (Corrective and Preventative Action) projects.
• Participate in both internal and external regulatory audits and inspections.
• Drive quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485, IEC62304, HIPAA, FDA, Security Standards, Data Privacy).
• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
• Conduct evaluation of software systems activities, including requirements, design, development, documentation, integration, test, verification, and validation.
• Define appropriate measures to ensure product quality.
• Develop overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
• Ensure that projects and process control documentation are compliant with requirements, objectives, and/or contracts.
• Review software systems design, change specifications, and plans against contractual and/or process requirements.
• Provide or direct verification and validation of software system requirements, traceability, and testability.

Required Skills:

• Bachelor s degree in engineering, Science, or Technical Field with 4 years of experience in Engineering, Software Development, and/or Quality OR Advanced Degree in Engineering, Science, or Technical Field with 2 years of experience in Engineering, Software Development, and/or Quality.
• Experience in software design and development, verification, validation, and testing activities, including embedded software and/or mobile application development (Java, Objective-C, Kotlin, Swift) and/or cloud infrastructure services (such as Amazon AWS, Microsoft Azure, IBM Watson).
• Experience executing in the SDLC environment leveraging ALM tools (e.g., PTC Integrity, Atlassian Suite, TFS), defect tracking tools (e.g., Jira), development tools (Git, SourceTree, Android Studio, GitLab), test tools (Selenium, JUnit), CI/CD tools (Jenkins).
• Exposure to medical device compliance standards (such as ISO13485, IEC62304, HIPAA, FDA, Security Standards, Data Privacy).
• Ability to author technical reports, business correspondence, and standard operating procedures.
• Exposure to data-driven insight solutions leveraging machine learning/artificial intelligence (AI).
• Exposure to wireless communication protocols (e.g., Bluetooth).
• Exposure to n-tier architecture models and/or experience with ITIL processes/IT systems.
• Working knowledge of integrated digital health systems, including consumer products such as Apple Inc./Android products.
• Certified Scrum Master or SAFe or Black Belt or Green Belt or CQE.
• Understanding and experience applying ISO 62304 and ISO 14971 standards, Risk Management Experience, New Product Development, Defect Management Experience, Software Agile Methodology.