Note: The job is a remote job and is open to candidates in USA. QvalFocus Inc. is seeking an experienced Senior Software Verification & Validation (V&V) Engineer to support software quality activities for regulated medical devices. This role will focus on Software Verification & Validation (V&V), Test Method Validation, and design assurance throughout the product development lifecycle.
Responsibilities
- Plan, develop, review, and execute Software Verification & Validation (V&V) activities for medical device software and embedded systems
- Develop, validate, and maintain test methods, verification protocols, validation plans, and test reports
- Perform Test Method Validation (TMV) to ensure test procedures are accurate, repeatable, and compliant
- Create and execute manual and automated software test cases at the unit, integration, system, and regression levels
- Review software requirements and maintain requirements traceability throughout the development lifecycle
- Support Design Verification and Design Validation activities in compliance with FDA Design Controls
- Investigate software defects, perform root cause analysis, and support CAPA activities
- Collaborate with Software Engineering, Systems Engineering, Quality, Regulatory, and Risk Management teams
- Support Design History File (DHF) documentation and software lifecycle deliverables
- Participate in design reviews, risk assessments, and software quality activities
Skills
- Bachelor's degree in Engineering, Computer Science, Software Engineering, or a related technical discipline
- 8+ years of Software Verification & Validation experience within the medical device industry
- Strong experience with Software Verification & Validation (V&V) and Test Method Validation
- Experience developing and executing software test protocols, validation plans, and verification reports
- Experience with embedded software or Software as a Medical Device (SaMD)
- Working knowledge of: IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820 / Design Controls
- Experience with requirements traceability, defect management, and software quality processes
- Excellent written and verbal communication skills
- Experience with Design Assurance or Software Quality Engineering
- Experience with automated testing frameworks and Hardware-in-the-Loop (HIL) testing
- Familiarity with tools such as DOORS, JIRA, HP ALM, TestStand, Jenkins, Windchill, Polarion, or similar
- Experience supporting Class II or Class III medical devices
- Experience with risk analysis, FMEA, CAPA, and Design History File (DHF) documentation
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