Description

You will manage end-to-end manual testing for medical devices in a regulated environment.

This role is on-site.

Responsibilities

• Design, write, and review test cases and plans based on functional and software requirements.
• Execute regression testing, defect logging, and analysis throughout the SDLX/STLC process.
• Develop system and user acceptance test protocols, including corresponding technical reports.
• Lead and mentor team members, handling effort estimation and work assignments.
• Coordinate with cross-functional stakeholders and customers for clarifications and feedback.

Required Skills

• 5+ years of experience in manual testing for medical devices.
• Proficiency in SDLX/STLC processes.
• Expertise in black box testing techniques.
• Experience creating System Test Protocols/Scripts and User Acceptance Test Protocols/Scripts.
• Ability to produce System Test Reports and User Acceptance Test Reports.
• Knowledge of ISO 13485, ISO 14971, and FDA regulations/guidelines.
• Experience performing risk assessments and compliance analysis.
• Ability to create documentation including User and Functional Requirements.
• Proven experience leading teams and conducting technical reviews of verification work products.

Key Skills

Education

Any Graduate