Sr. Software Quality Engineer
- Pyramid Consulting Inc.
1 Days Ago
NA
C2C
Northridge-CA
7-10 Years
Required Skills: Software design and development, verification, validation, testing activities
Job Description
• Engage as a quality core team member responsible for driving quality into the design and development of digital health solutions (medical mobile device applications (iOS/Android)/cloud technologies - AWS/Client Watson)/data reports/AI/ML).
• Drive the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D/Regulatory/Marketing/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 FMEA’s.
• 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).
• Responsibilities may also include the following and other duties may be assigned.
• Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
• Defines appropriate measures to ensure product quality.
• Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
• Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
• Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
• Reviews include applicable specifications, materials, tools, techniques, and methodologies.
• Provides or directs verification and validation of software system requirements, traceability, and testability.
Minimum Qualifications:
• Bachelor’s degree in engineering, Science or Technical Field with 4+ years of experience in Engineering, Software Development and/or Quality OR Advanced Degree Engineering, Science or Technical Field with 2+ years of experience in Engineering, Software Development and/or Quality
Nice to Have:
• Experience in software design and development, verification, validation and testing activities. [embedded software and/or mobile application development [(Java (objective-C), and Kotlin (Swift)) and/or cloud infrastructure services (such as Amazon AWS/Microsoft Azure/Client Watson).
• Experience executing in the SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite/Client), defect tracking tools (Eg: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 in data driven insight solutions leveraging machine learning/artificial intelligence (AI).
• Exposure with wireless communication protocols (Eg: 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 to apply ISO 62304 and ISO 14971 standards, Risk Management Experience, New Product Development, Defect Management Experience, Software Agile Methodology
• Bachelor’s degree in engineering, Science or Technical Field with 4+ years of experience in Engineering, Software Development and/or Quality OR Advanced
• Degree Engineering, Science or Technical Field with 2+ years of experience in Engineering, Software Development and/or Qualit
