SoftwareÂ ValidationÂ Engineer

Plymouth - USA

Monthly Salary: Not Disclosed

Posted on: 05-09-2025

Vacancies: 1 Vacancy

Job Summary

Roles & Responsibilities:

Bachelors degree in computer science Information Technology Electronics Engineering or a related field.
Minimum 5-8 years of experience in software validation preferably within the medical device pharmaceutical or regulated healthcare industries.
Strong understanding of software development lifecycle (SDLC) methodologies validation planning risk management and quality assurance principles.
Experience in handling SW development and verification tools.
Good exposure to FDA regulations (21 CFR Part 11 Part 820) ISO 13485 EU MDR GAMP 5 and other relevant standards for software lifecycle and validation.
Experience with computerized system validation (CSV) approaches for non-product applications.
Proficiency in authoring validation documents as per SOP or work instruction.
Responsible for SW Validation planning requirement gathering Risk assessment protocol development and test execution.
Work with cross functional team and SME to understand the intended use and prepare the above documentation.

Roles & Responsibilities: Bachelors degree in computer science Information Technology Electronics Engineering or a related field. Minimum 5-8 years of experience in software validation preferably within the medical device pharmaceutical or regulated healthcare industries. Strong understanding of s...