Test Lab Consultant – Medical Devices

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 testing should be conducted internally versus through NABL-accredited / appropriately qualified external laboratories.
C. Standards & Regulatory Compliance
Identify applicable standards for each medical-device product.
Develop a Product Testing & Standards Matrix.
Support interpretation and implementation of applicable:
ISO standards
IEC standards
BIS standards
CDSCO requirements
Indian Pharmacopoeia / applicable pharmacopeial requirements
International standards where applicable
Review test reports for adequacy and regulatory acceptability.
Support preparation of technical documentation and Design Dossiers / Technical Documentation.
Provide technical inputs during regulatory audits and inspections.
D. Test Protocol & Report Development
Develop and review:
Test protocols
Test methods
Work instructions
Test specifications
Acceptance criteria
Test reports
Verification protocols
Validation protocols
Equipment qualification protocols
Ensure traceability between design inputs → risks → verification requirements → test methods → acceptance criteria → test results.
Review deviations, failures and out-of-specification results.
E. Laboratory Quality System
Support implementation of laboratory controls including:
Equipment calibration system
Preventive maintenance
Equipment qualification
Reference standards
Measurement traceability
Test sample identification and traceability
Data integrity
Test-result review and approval
Laboratory SOPs
Environmental monitoring
Record retention
Training and competency assessment
Where applicable, support the organization toward ISO/IEC 17025 laboratory requirements.
F. Equipment Qualification
Support qualification of critical test equipment through:
URS – User Requirement Specification
DQ – Design Qualification
IQ – Installation Qualification
OQ – Operational Qualification
PQ – Performance Qualification
Calibration
Periodic verification
Preventive maintenance
G. Failure Investigation & Root Cause Analysis
Review failed or abnormal test results.
Lead/support root-cause investigations.
Use appropriate tools such as:
5 Why
Fishbone Analysis
Fault Tree Analysis
FMEA
DOE, where appropriate
Recommend corrective and preventive actions.
Support CAPA implementation and effectiveness verification.
H. External Laboratory Management
Identify and technically evaluate external testing laboratories.
Review laboratory accreditation and scope.
Prepare RFQs and technical test requirements.
Evaluate quotations and testing proposals.
Coordinate testing schedules and sample requirements.
Review external test reports for completeness and compliance.
Maintain an approved external laboratory list.
3. Key Deliverables
The consultant will be expected to deliver, as applicable:
Test Laboratory Setup Plan
Laboratory Master Equipment List
Equipment Technical Specifications / URS
Product Test Matrix
Applicable Standards Matrix
Test Method & Protocol Templates
Laboratory SOP Framework
Equipment Qualification Plan
Calibration & Maintenance Plan
Internal vs. External Testing Strategy
Test Report Review Framework
Laboratory Documentation System
Testing Cost Optimization Plan
Laboratory Readiness / Gap Assessment Report
Support for regulatory and quality audits
4. Qualification & Experience
Education:
B.E./B.Tech/M.Tech in Mechanical, Electrical, Electronics, Biomedical, Instrumentation, Medical Engineering, or related discipline.
Additional qualification in Quality, Regulatory Affairs or Testing will be an advantage.
Experience:
Typically 10–15+ years of relevant experience in medical-device testing, product verification/validation, laboratory management or quality engineering.
Strong experience with medical-device testing and applicable international standards.
Experience in setting up or managing testing laboratories is highly desirable.
Experience with CDSCO submissions and technical documentation will be preferred.
Experience working with NABL / ISO/IEC 17025 laboratories will be an advantage.
5. Technical Competencies
The consultant should have strong knowledge of:
Medical-device V&V
Design verification and validation
Test method development
Risk management – ISO 14971
Quality management – ISO 13485
Electrical safety – IEC 60601-1, where applicable
EMC – IEC 60601-1-2, where applicable
Software lifecycle – IEC 62304, where applicable
Usability engineering – IEC 62366, where applicable
Biocompatibility – ISO 10993 series, where applicable
Packaging – ISO 11607 series, where applicable
Environmental and reliability testing
Calibration and measurement systems
ISO/IEC 17025 laboratory practices
Statistical analysis and test-data interpretation
6. Preferred Product Experience
Experience with one or more of the following medical-device categories will be preferred:
X-Ray / Medical Imaging Systems
Mobile DR
Surgical Robotics
Patient Monitoring Systems
Infusion / Drug Delivery Devices
Diagnostic Devices
IVD Products
Electromechanical Medical Devices
Wearable Medical Devices
Surgical Devices
Rehabilitation / Assistive Devices
7. Key Performance Indicators (KPIs)
Laboratory setup completed as per approved timeline.
Testing equipment specification and procurement support.
Percentage of tests successfully completed according to approved protocols.
Reduction in external testing dependency and cost where technically/regulatorily appropriate.
Test-report quality and regulatory acceptance.
Calibration compliance.
Laboratory audit readiness.
Timely closure of test failures and deviations.
Traceability and completeness of verification documentation.
8. Engagement Model

Work arrangement
No