Job Description
Summary :
Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards.
Roles & Responsibilities :
Prepare test samples and fixtures for mechanical and functional testing.
Execute tests and document results per Good Documentation Practices (GDP).Generate Test Reports for inclusion in the Design History File (DHF).
Coordinate with cross-functional teams to ensure timely completion of testing activities. Education & Experience : Hands-on experience with mechanical testing and data acquisition systems.
Ability to interpret engineering drawings and specifications.
Familiarity with ISO and FDA QSR requirements preferred.
Experience Required - years.
Develop Test Protocols aligned with design verification plans and regulatory requirements.