Position
Designation: Test Lab Consultant
Department: Quality / R&D; / Regulatory
Engagement: Consultant / Part time / Project-based
Location: Noida / Gurugram, India
Reporting To: Head – Quality / Operations

1. Role Objective

The Test Lab Consultant will be responsible for providing technical and strategic guidance for the planning, establishment, qualification, operation, and continuous improvement of testing laboratory facilities for medical devices.

The consultant will support the organization in defining appropriate test methods, selecting test equipment, developing test protocols, evaluating external and internal laboratory capabilities, and ensuring that testing activities comply with applicable ISO, IEC, BIS, CDSCO and other relevant regulatory requirements.

2. Key Responsibilities

A. Test Laboratory Setup & Planning

Develop the overall test laboratory concept, infrastructure and equipment requirements.
Prepare a comprehensive Test Laboratory Master Equipment List.
Define equipment specifications, capacity and performance requirements.
Recommend suitable test instruments,



fixtures, gauges and measurement systems.
Support vendor identification, technical evaluation and comparison of quotations.
Define laboratory layout, utilities, environmental requirements and safety provisions.
Establish requirements for calibration, maintenance and equipment qualification.

B. Medical Device Testing

Provide technical guidance for testing of medical devices, including as applicable:
Electrical safety testing
EMC testing
Mechanical and structural testing
Environmental testing
Performance and functional testing
Software / firmware verification support
Battery and electrical system testing
Biocompatibility test coordination
Packaging and transportation testing
Shelf-life and accelerated-aging studies
Sterilization-related testing
Usability-related verification support
Reliability and endurance testing
Risk-control verification testing

The consultant shall identify when

📌 Test Lab Consultant – Medical Devices (Noida)
🏢 SHUKRA PHARMACEUTICALS
📍 Noida