Job Description Summary

Job Description

Assists in the generation and execution of formal test protocols and reports.
• Sets up and operates test equipment and records measurements with limited supervision.
• Manages testing of released protocols, including insuring adequate test material inventory and reports on a project level.
• Executes Continuous Improvement projects in the following (but not limited to) areas

Equipment or method troubleshooting/repairs
o Coordinates with Test Method Development and Verification & Validation team for equipment and method validations
o Method or Equipment Upgrades
o Fixture maintenance
o Drawing or Specification modifications
• The incumbent will also work with the team on product failure, defect management and CAPA investigations.
• Assists in statistical analysis of data.
• Maintain an R&D Laboratory Notebook
• Coordinates Calibration / Preventive Maintenance / repair schedule and documentation
• Maintains the Tool Crib and Fixture inventory.
• Manages the chemical inventory and Medical Safety Data Sheets (MSDS) upkeep. Ensures timely removal of expired chemicals
• Responsible for assisting in evaluation of new products, materials / technologies, and non-conforming product investigations.
• Provides process/test method training to Manufacturing/QC personnel and other technicians.
• Develops and maintains a working knowledge of BD policies and procedures aligned with ISO and FDA requirements
• Must be able to work in a bio-hazard environment and comply with safety policies and procedures outlined by BD policies.
• Support internal / external audit requirements for Lab

Knowledge and Skills
a. Knowledge
 Standard laboratory practices.
 Data collection, management, and analysis
 Inventory management
 Basic of statistics
 Lab maintenance
 Quality Inspection techniques
 Vendor management
 Medical Regulatory Standards
b. Skills
 Technical Writing
 Good communication skills (written/verbal)
 Equipment Programming

Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
 Materials / Chemicals knowledge
 Project Management
 CAD modelling [SOLIDWORKS / AutoCAD]
 Medical devices / products
9. Any additional Information (Specially if needed for Quality or legal purposes)
• The ideal candidate must be able to work in a team oriented, fast paced environment.

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift