Description

You will own the end-to-end testing lifecycle for medical device software within a regulated environment.

Responsibilities

• Execute manual testing, defect logging, and defect analysis throughout the SDLC/STLC.
• Design, write, and review test plans, test cases, and system test protocols using black box techniques.
• Draft compliance documentation including Risk Assessments, User Requirements, and Functional Requirements.
• Lead and mentor team members, including effort estimation and work assignment.
• Coordinate with cross-functional stakeholders and customers to obtain technical clarifications and feedback.

Required Skills

• 5+ years of experience in manual testing for medical devices.
• Proficiency in Test Planning, Test Case Design, and Test Case Writing.
• Experience with User Acceptance Test (UAT) protocols and reports.
• Hands-on knowledge of SDLC and STLC processes.
• Ability to create test cases directly from Functional Specifications or Software Requirement Specifications.
• Familiarity with ISO 13485 and ISO 14971 standards.
• Working knowledge of FDA regulations and guidelines.
• Experience performing regression testing and technical reviews of verification work products.
• Any Graduate degree.

Key Skills

Education

Any Graduate