Description

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

Responsibilities

• Design, write, and review test cases and test plans based on functional and software requirement specifications.
• Execute regression testing, defect logging, and defect analysis throughout the SDLX/STLC process.
• Develop system test protocols, user acceptance test protocols, and corresponding technical reports.
• Lead and mentor team members, including effort estimation and work assignment.
• Coordinate with cross-functional stakeholders and customers to obtain clarifications and feedback.
• Manage release deliverables, compliance analysis, and project administrative activities.

Required Skills

• 5+ years of experience in manual testing for medical devices.
• Proficiency in SDLX/STLC processes.
• Expertise in Black box testing techniques.
• Experience with 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 Requirements and Functional Requirements.
• Proven experience leading teams and conducting technical reviews of verification work products.

Preferred Skills

• Experience working independently with customers to drive project requirements.

Key Skills

Education

Any Graduate