Sr. Software Quality Engineer
Three Point Solutions
Job title : Sr. Software Quality Engineer
Client : Medical Device Manufacturing Company
Duration : 12 months + possible extension
Location : Northridge CA
Schedule : 1st Shift | New Haven site | 4 days/week onsite Key Responsibilities
Must-Have Technical Skills
ISO 62304 | ISO 14971 | Risk Management | New Product Development | Defect Management | Software V&V | Agile Methodology #ZR
Client : Medical Device Manufacturing Company
Duration : 12 months + possible extension
Location : Northridge CA
Schedule : 1st Shift | New Haven site | 4 days/week onsite Key Responsibilities
- Drive software quality for digital health solutions including iOS/Android mobile apps, AWS/IBM Watson cloud, data reporting, AI/ML.
- Develop and execute quality strategies with R&D, Regulatory, Marketing, and Operations teams.
- Drive quality throughout the SDLC using Agile, Waterfall, SAFe, and DevOps.
- Define/review requirements, design, verification & validation (V&V), test plans, and traceability.
- Participate in design reviews and approve requirements, design documents, code reviews, test results, V&V reports, and defects.
- Lead software risk management, system risk analysis, and Software FMEA.
- Lead CAPA projects and support internal/external regulatory audits and inspections.
- Drive compliance with ISO 13485, IEC 62304, ISO 14971, HIPAA, FDA, Security & Data Privacy requirements.
- Establish and maintain software quality processes, procedures, metrics, documentation, and controls.
- Evaluate software requirements, design, development, integration, testing, verification, and validation.
- Ensure traceability, testability, documentation, and process compliance.
- Bachelor's degree in Engineering, Science, or Technical field + 4+ years Engineering/Software Development/Quality experience.
- OR Advanced degree in Engineering, Science, or Technical field + 2+ years relevant experience.
- Software design, development, V&V, and testing experience.
- Embedded software/mobile apps: Java, Objective-C, Kotlin, Swift.
- Cloud: AWS, Azure, IBM Watson.
- ALM/Defect/Development/Test/CI-CD: PTC Integrity, Atlassian, TFS, Jira, Git, GitLab, Android Studio, Selenium, JUnit, Jenkins.
- Medical device standards: ISO 13485, IEC 62304, ISO 14971, HIPAA, FDA, Security/Data Privacy.
- AI/ML, data-driven solutions, wireless/Bluetooth, n-tier architecture, ITIL.
- Digital health systems and Apple/Android products.
- Certifications: Scrum Master, SAFe, Black Belt, Green Belt, or CQE.
Must-Have Technical Skills
ISO 62304 | ISO 14971 | Risk Management | New Product Development | Defect Management | Software V&V | Agile Methodology #ZR
Vacancy posted 9 hours ago
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