M
Sr. Software Quality Engineer
Mindlance
🇺🇸 United States
On-site
Senior
1 month ago
$53.17 – $55.17 / hour
- iOS
- Android
- AWS
- AI/ML
- Agile
- Waterfall
- Devops
- Risk Management
- FMEA
- CAPA
- HIPAA
- Java
- Kotlin
- Swift
- Azure
- Atlassian
- TFS
- Jira
- Git
- Android Studio
- GitLab
- Selenium
- JUnit
- CI/CD
- Jenkins
- Machine Learning
- AI
- ITIL
- Certified Scrum Master
- Black Belt
- Green Belt
1 month ago
| Bill Rate | $80/hr USD |
| 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/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 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/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 CQE |
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Sr. Software Quality Engineer · Mindlance