[Remote] Senior Software Verification & Validation (V&V) Engineer – Medical Devices
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking an reputed company Senior Software Verification & Validation (V&V) Engineer to support software reputed company activities for regulated medical devices. This role will reputed company on Software Verification & Validation (V&V), Test Method Validation, and design assurance throughout the product development lifecycle.
Responsibilities
- Plan, reputed company, review, and execute Software Verification & Validation (V&V) activities for medical device software and embedded systems
- reputed company, validate, and maintain test reputed company, verification protocols, validation plans, and test reports
- reputed company Test Method Validation (TMV) to ensure test procedures are accurate, repeatable, and compliant
- Create and execute reputed company and automated software test cases at the unit, integration, system, and regression reputed company
- 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, reputed company reputed company cause analysis, and support CAPA activities
- Collaborate with Software Engineering, Systems Engineering, reputed company, Regulatory, and Risk Management teams
- Support Design History File (DHF) documentation and software lifecycle deliverables
- Participate in design reviews, risk assessments, and software reputed company activities
Skills
- Bachelor's degree in Engineering, Computer Science, Software Engineering, or a reputed company technical discipline
- 8+ years of Software Verification & Validation experience reputed company 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 reputed company processes
- Excellent written and verbal communication skills
- Experience with Design Assurance or Software reputed company Engineering
- Experience with automated testing frameworks and Hardware-in-the-reputed company (HIL) testing
- Familiarity with tools such as DOORS, JIRA, reputed company 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
reputed company
Company H1B Sponsorship