
Sr. Engineer, Lab Technician
- Bangalore, Karnataka
- Permanent
- Full-time
- Sets up and operates test equipment and records measurements with limited supervision.
- Assists in the generation and execution of formal test protocols and reports.
- Ensures equipment is in good working order prior to testing (via verification prior to use).
- Manages testing of released protocols, including insuring adequate test material inventory and reports on program level.
- Executes Continuous Improvement projects in the following (but not limited to) areas:
- Coordinates with Test Method Development and Verification team for equipment and method validations
- Method or Equipment Upgrades
- 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
- Responsible for assisting in evaluation of new products, materials / technologies, and non-conforming product investigations.
- Develops and maintains a working knowledge of Baxter 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
- Standard laboratory practices.
- Data collection, management, and analysis
- Inventory management
- Basic of statistics
- Lab maintenance
- Quality Inspection techniques
- Vendor management
- Medical Regulatory Standards
- 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)
- Medical devices / products
- The ideal candidate must be able to work in a team oriented, fast paced environment.
- Knowledge of medical device software development is highly preferred including knowledge of standards such as IEC 62304, ISO 14971