Job title: V&V Engineer
About Us
Vaisesika is an ISO 27001 certified innovative and value driven company in the business of Software Development, Quality Engineering, Validated Testing, ERP services, Cloud Migration & DevOps, RPA, Data Analytics & Business Intelligence. We have offices in USA, Canada, India and UAE. We have been able to work in multiple projects in various domains ranging from Healthcare & Lifesciences, BFSI, e-commerce, Retail and we pride ourselves as one of the industry leaders in these areas.
Responsibilities
Ø Plan, execute, and document verification and validation (V&V) activities to ensure products meet functional, performance, and regulatory requirements.
Ø Apply human factors engineering principles to product development and lead usability studies and assessments as part of V&V activities.
Ø Develop and execute test protocols and test plans, including in vitro and in vivo testing, and analyze results to support product validation.
Ø Maintain traceability between user needs, design inputs, and validation activities throughout the product development lifecycle.
Ø Prepare and maintain V&V reports and documentation in compliance with regulatory requirements, including FDA expectations.
Ø Collaborate cross-functionally with design, development, regulatory, and quality teams to integrate V&V activities into product development processes
Ø Identify opportunities to improve V&V processes, documentation, and testing strategies to increase efficiency, quality, and compliance.
Ø 3–7 years of experience in Verification & Validation engineering within a regulated industry, preferably medical devices.
Ø Demonstrated experience applying human factors engineering principles and conducting usability studies or assessments.
Ø Hands-on experience developing and executing V&V protocols, test plans, and validation documentation.
Ø Strong knowledge of FDA regulatory requirements, including V&V documentation expectations under 21 CFR Part 820.
Ø Experience establishing and maintaining requirements traceability across user needs, design inputs, and validation activities.
Ø Strong written and verbal communication skills in English, with the ability to produce clear technical documentation and reports.
Ø Ability to work collaboratively in cross-functional teams while managing multiple priorities in a regulated development environment.
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