Andreas Ahha
e-mail: ***********@*****.***
Address:
Mobile Phone #112
Number: San Diego, CA 92130
Background
Senior Manager with more than 12 years of experience in FDA
regulated environments. Proven track record in growing organizations and
managing groups of multiple disciplines.
Professional Timeli
2011-2012 Accumetrics Inc.
Senior Director Development & Engineering
A developer and manufacturer of the VerifyNow platelet
function analysis instrument and disposable devices.
Development of the second generation VerifyNow instrument
with the ability to report results from a blood collection
tube and a disposable cartridge. The analyzer operates on a
multiprocessor platform with a graphical user interface and
capacitive touchscreen.
Led the electrical engineering, software engineering,
mechanical engineering and validation engineering groups.
Transfer to manufacturing and optimization of production
practices in accordance with GMP and ISO 14971 Medical
devices standards. Design Control and validations in
accordance with 21 CFR Part 820 - Quality System Regulation
including software and hardware design control.
Features included:
Advanced algorithm based data analysis of sampled data for
optimization of reported results.
Onboard real time response data processing and analysis
Network data interface capability as well as external data
storage.
Multiple barcode readers for patient data collection and
automatic cartridge information processing
Real time opto-pneumatic computer control and data collection
Onboard printer, internal calibration management
2008-2010 CE, CSA and TUV international markings testing and approvals.
Scientronics Ltd.
Executive Director
Disrtibutor of Diagnostics Products Corporation (DPC), Bayer,
Siemens, Quiagen, Biosite, Menarini and J&J Ortho Clinical.
Lead the definition and execution of the company's new
strategic plan. Reporting departments incluted operations,
customer support, technical support, logistics and scientific
support (excluding the sales department). New structure
resulted in a 225% growth and 25% increase in sales revenues
2000-2007 including the successful completion and integration of two
distributorship acquisitions.
Biosite Inc.
San Diego, California, USA
Sr. Director Engineering
A developer and manufacturer of Immunoassay/Proteomic POC
diagnostics. Acquired in 2007 by Invernes Medical (Alere) for
$1.57B.
Led the growth and operation of the departments of:
Control electronics
Software development
Process engineering
Advanced automation
Design
Managed the development of the next generation low cost,
miniaturized instrument in collaboration with Agilent's bio
division.
Led the development of the company's next generation single
step microarray immunoassay biochip.
Managed multiple multimillion dollar advanced automation
1998-2000 projects for the production of disposable microfluidic
immunoassay devices. Projects included collaborations with
national and international automation houses. The capacity
expansions resulted in manufacturing capacity increase from 2
million to 11 million devices per year.
Vectrex Inc.
San Diego, California, USA
Biomedical Consulting Engineer
Design and development of electronic and software systems for
Biomedical and Biotechnology research and production.
Education
Arizona State University ASU
. B.Sc., Biomedical Engineering, Biosystems
University California San Diego UCSD
. Graduate work in Executive Leadership,
Enterprise Dynamics and
Applied Innovation
Awards
Biosite Inc.
2006 Outstanding Achievement Award for Capacity
Expansion
2002 Outstanding Achievement Award for Product
Transfer
2001 Outstanding Achievement Award for Microarray
development