Sr. Software Quality Engineer

Quality Core Team MemberBill Rate - $80/hr USDJob 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/IBM 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 QualityNice 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/IBM Watson)].• Experience executing in the SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite/TFS), 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 CQEEEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."