Senior Process Engineer Resume

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.