6219 Gibson Court
Pleasanton, CA 94588
Michael Winer
Summary
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Experience
925.899.6031 cell
mlwiner@yahoo.com
15 years in development, manufacturing-process engineering
10+ years experience in cGMP/ISO; implantable-cardiovascular,
drug delivery (pulmonary/needle free) and diagnostics
Design for manufacturing and assembly (DFM/DFA)
Facility layout, tooling/fixture and workcenter implementation
Process development and characterization (design of experiments – DoE/SPC)
Validation program development and management
Corrective/preventative action identification/implementation
Production and Project Management
Direct interface with auditors, customers/partners, CMO’s, int’l and regulatory agencies
MBA & BSME
NOVO NORDISK DELIVERY TECHNOLOGIES (NNDT), Hayward, CA
(Division of Novo Nordisk spun-off from Aradigm)
2005 -
Manufacturing Project Manager
 Program development/coordination, production planning and validation of the AERx™
iDMS electromechanical pulmonary drug delivery device. Develop and implement clinical
scale-up (including staffing) and commercial scale-up strategies.
New facility
development. Staff development.
ARADIGM CORPORATION, Hayward, CA
1998 - 2005
Device Production Manager (Mar 01 thru Mar 05)
 Direct a team of senior production technicians in successful Phase I/II/III clinical
campaigns for the AERx™ electromechanical pulmonary drug delivery device. Facility
layout and revision to improve throughput. Process development, validation planning
and achievement. FMEA/FMECA. Develop commercial scale-up strategies. Intraject®
needle-free tech-transfer and integration. Staff development.
Senior Manufacturing Engineer (Dec 98 – Mar 01)
 Lead Manufacturing Engineer for new product introduction of AERx™ insulin pulmonary
drug delivery device. Responsible for manufacturing process set-up, layout,
documentation, training and validation activity. Created and implemented a flexible
manufacturing process. Develop clinical supply kits, including packaging/labeling.
Perform failure analysis and implement corrective action.
THORATEC CORPORATION, Pleasanton, CA
1997 – 1998
Senior Manufacturing Engineer
 New product introduction of ventricular assist device (VAD) TLC-II™ portable pneumatic
drive system. New facility manufacturing set-up and validation for all VAD and cannulae
polymer processes and the TLC-II™ portable driver. Develop and implement new
manufacturing processing polymer equipment/tooling. Resolve customer complaints.
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ABBOTT /HEMATOLOGY BUSINESS UNIT, Santa Clara, CA
1996 – 1997
Manufacturing Engineer
 Develop and validate design changes and assembly/test processes for the manufacture
of automated blood analyzers (red/white blood cell diagnostics). Provide manufacturing
input for FMEA/FMECA. Direct and train manufacturing personnel. Prepared detailed
cost analyses for new product introduction.
ST. JUDE MEDICAL CRM (Ventritex), Sunnyvale, CA
1993 – 1996
Manufacturing Process Engineer
 Develop and validate processes for the manufacture of implantable cardiac
pacemaker/defibrillators (ICD’s). Project leader for process validation effort. Technical
resource for design of experiments/SPC. Develop and implement SOP’s for validation,
equipment/tooling, and non-conforming materials.
GOODRICH AEROSTRUCTURES (Formerly Rohr), Chula Vista, CA
1990 – 1993
Standards & Equipment Engineer
 Developed specifications and qualification test procedures for electro-mechanical,
pneumatic/hydraulic equipment and hardware for commercial aircraft high bypass
turbofan engines. Cost reduction/second-sourcing. Led failure analyses; developed and
implemented corrective actions. Continuous Process Improvement (CPI) Team.
Education
MBA, Saint Mary’s College, Moraga, CA, 2001
BS Mechanical Engineering, San Diego State University, San Diego, CA, 1990
Computer
Proficiency
Michael Winer
MS Project, Excel, Word, Access, PowerPoint, JDEdwards (MRP), Visio.
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