PROFESSIONAL EXPERIENCE

Senior Process Engineer

Confidential

Responsibilities:

• Core Engineer responsible for developing and scaling - up Manufacturing systems for Freestyle Navigator - Confidential ’s Implantable Glucose Monitoring Device.
• Instrumental in launching Freestyle Navigator in both US and Europe with FDA/CE approval.
• Worked with R&D Chemists and Engineers to Design, Develop and Evaluate prototypes and monitor the progress through Confidential ’s product development cycle.
• Investigated new raw materials, sensor components, and worked with in-house Clinical trial teams to approve materials and vendors.
• Conducted DOEs, FMEAs and Reliability Studies to improve Product performance and Manufacturing Processes using Six Sigma principles.
• Experienced with Document Control Process including Requirement Specifications, IQ/OQ/PQ protocols, batch records, work instructions etc. Worked with QA/QC teams to write Documents covering Changes related to Product Design and Process Improvement.

Senior Engineer & Program Manager

Confidential

Responsibilities:

• Key member of a scientific team in a Start-up company responsible for the development of miniaturized DNA analysis instruments for fast, accurate, and affordable diagnostic testing.
• Program Manager on a Department of Defense contract (~ $8 Million) to develop hand-held instruments for detecting bio-warfare agents like anthrax & plague
• Conducted DOEs, FMEAs to troubleshoot and improved Instrument Design and Performance. Conducted Reliability Analysis (Software& hardware) for Diagnostic Devices.
• Managed several aspects of the Documents Control System and Regulatory Affairs covering Product Design, Development and Manufacturing under cGMP, GLP requirements
• Managed Research Associates, Research Assistants and interns
• Written grants, federal contracts and secured funds amounting to $10 million.